Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies (NCT NCT02061761)
NCT ID: NCT02061761
Last Updated: 2023-03-24
Results Overview
Number of participants with any grade adverse events (AEs), any grade serious adverse events (SAEs) and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
106 participants
Primary outcome timeframe
From first dose to 100 days post last dose (Up to 51 months)
Results posted on
2023-03-24
Participant Flow
Participant milestones
| Measure |
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
Dose escalation (part A): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg Part B
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab Part D
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
6
|
9
|
11
|
7
|
1
|
4
|
56
|
|
Overall Study
Chronic Lymphocytic Leukemia (CLL)
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Diffuse Large B-Cell Lymphoma (DLBCL)
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
15
|
|
Overall Study
Indolent Non-Hodgkin Lymphoma (iNHL)
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Hodgkin Lymphoma (HL)
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
HL-anti-PD-1 Naive
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
|
Overall Study
HL-anti-PD-1 Progressed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
6
|
9
|
11
|
5
|
1
|
4
|
51
|
Reasons for withdrawal
| Measure |
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
Dose escalation (part A): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg Part B
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab Part D
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
2
|
8
|
4
|
5
|
9
|
3
|
1
|
2
|
28
|
|
Overall Study
Study Drug toxicity
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
6
|
|
Overall Study
Adverse event unrelated to study Drug
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant request to discontinue study treatment
|
0
|
0
|
2
|
2
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Maximum clinical benefit
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
6
|
|
Overall Study
Participant no longer meets study criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other reasons
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
6
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
Baseline characteristics by cohort
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=9 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=6 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=60 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
Total
n=106 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
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
72 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
34 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
68 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
102 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=24 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
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 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
|
4 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
83 Participants
n=24 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Up to 51 months)Population: All treated participants
Number of participants with any grade adverse events (AEs), any grade serious adverse events (SAEs) and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=9 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=6 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=60 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
AEs
|
3 Participants
|
9 Participants
|
5 Participants
|
19 Participants
|
7 Participants
|
1 Participants
|
59 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
SAEs
|
1 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
26 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
AEs leading to discontinuation
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From first dose to 135 days post last dose (Up to 52 months)Population: All treated participants
Number of participants who died due to any cause.
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=9 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=6 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=60 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 49 months)Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter
Number of participants with laboratory abnormalities in specific hepatic tests based on SI unit convention. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=9 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=5 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=57 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
ALT OR AST > 3XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
TOTAL BILIRUBIN > 2XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
ALP > 1.5XULN
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN ONE DAY
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 1.5XULN WITHIN 30 DAYS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
ALT OR AST > 5XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
ALT OR AST > 10XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose date to the date of disease progression per investigator or the date of subsequent therapy, whichever occurs first (Up to approximately 95 months)Population: Pre-specified only to be collected in all treated participants by tumor type for Part D
Investigator-assessed ORR per International Working Group (IWG 2007) response criteria for malignant lymphoma is defined as the number of participants with a best overall documented response (BOR) of either a complete response (CR) or partial response (PR). Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. \>= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions). Progressive disease: Any new lesion or increase by \>=50% of previously involved sites from nadir.
Outcome measures
| Measure |
BMS-986016 20mg
n=21 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=15 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=20 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) - Part D
|
61.9 Percentage of participants
Interval 38.4 to 81.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
15.0 Percentage of participants
Interval 3.2 to 37.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (Up to approximately 95 months)Population: Pre-specified only to be collected in all responders (CR or PR) by tumor type for Part D
Investigator-assessed DoR per International Working Group (IWG 2007)) response criteria for malignant lymphoma is defined as the time between the date of first documented response (complete response or partial response) to the date of the first objectively documented progression, or death due to any cause, whichever occurs first. Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. \>= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions). Progressive disease: Any new lesion or increase by \>=50% of previously involved sites from nadir.
Outcome measures
| Measure |
BMS-986016 20mg
n=13 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=1 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=3 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) - Part D
|
14.16 Months
Interval 2.56 to
Upper limit not available due to insufficient number of participants with events
|
NA Months
insufficient number of participants with events
|
6.37 Months
Interval 1.84 to
Upper limit not available due to insufficient number of participants with events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 Maximum Observed Serum Concentration (Cmax). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=7 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=6 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=37 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Maximum Observed Serum Concentration (Cmax)
P0C3D1
|
6.660 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21
|
31.917 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 81
|
673.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
116.419 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 49
|
44.532 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 12
|
149.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
88.196 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 44
|
|
BMS-986016 Maximum Observed Serum Concentration (Cmax)
Period 0, Cycle 1, Day 1 (P0C1D1)
|
3.697 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
|
22.738 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 29
|
224.802 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 32
|
68.718 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54
|
19.990 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25
|
57.900 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
40.402 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 26
|
|
BMS-986016 Maximum Observed Serum Concentration (Cmax)
P1C1D1
|
—
|
—
|
—
|
—
|
—
|
59.600 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
68.400 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Maximum Observed Serum Concentration (Cmax)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
165.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
163.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax). Period 0 = treatment period Period 1 = Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=7 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=6 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=37 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
Period 0, Cycle 1, Day 1 (P0C1D1)
|
0.97 Hours
Interval 0.97 to 0.97
|
1.300 Hours
Interval 1.0 to 4.0
|
4.167 Hours
Interval 1.0 to 24.0
|
1.825 Hours
Interval 0.97 to 95.75
|
3.950 Hours
Interval 1.0 to 5.0
|
0.97 Hours
Interval 0.97 to 0.97
|
1.600 Hours
Interval 0.97 to 24.07
|
|
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
P0C3D1
|
0.984 Hours
Interval 0.97 to 1.0
|
10.975 Hours
Interval 1.37 to 20.58
|
168.22 Hours
Interval 168.22 to 168.22
|
1.233 Hours
Interval 0.97 to 23.87
|
1.017 Hours
Interval 1.0 to 4.0
|
1.000 Hours
Interval 1.0 to 1.0
|
3.467 Hours
Interval 0.92 to 46.45
|
|
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
P1C1D1
|
—
|
—
|
—
|
—
|
—
|
4.000 Hours
Interval 4.0 to 4.0
|
1.750 Hours
Interval 1.75 to 1.75
|
|
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
24.000 Hours
Interval 24.0 to 24.0
|
0.900 Hours
Interval 0.9 to 0.9
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 Area under the concentration-time curve in one dosing interval (AUC(TAU)). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=7 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=6 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=20 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=37 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
Period 0, Cycle 1, Day 1 (P0C1D1)
|
401.438 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 38
|
2852.533 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57
|
44296.525 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20
|
9086.827 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
|
2908.011 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 38
|
9480.758 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
5327.954 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
|
|
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
P0C3D1
|
712.408 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 6
|
4898.034 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 116
|
176405.369 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
18783.970 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 87
|
6166.165 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64
|
34573.957 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
20464.075 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 48
|
|
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
P1C1D1
|
—
|
—
|
—
|
—
|
—
|
11259.871 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
11433.253 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
38472.003 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
33919.259 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 Concentration at the end of a dosing interval (Ctau). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=7 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=5 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=18 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=26 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Concentration at the End of a Dosing Interval (Ctau)
P0C3D1
|
0.256 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 125
|
2.266 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 140
|
293.000 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
30.970 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 110
|
9.556 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78
|
103.000 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
47.016 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54
|
|
BMS-986016 Concentration at the End of a Dosing Interval (Ctau)
P1C1D1
|
—
|
—
|
—
|
—
|
—
|
25.900 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
24.200 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Concentration at the End of a Dosing Interval (Ctau)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
86.600 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
86.100 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Concentration at the End of a Dosing Interval (Ctau)
Period 0, Cycle 1, Day 1 (P0C1D1)
|
0.158 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 79
|
1.037 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 86
|
75.589 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31
|
12.221 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75
|
3.848 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53
|
19.500 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
8.417 h*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 effective elimination half-life that explains the degree of AUC accumulation observed (t 1/2eff AUC). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=2 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=1 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=1 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=5 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=2 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=12 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Effective Elimination Half-life That Explains the Degree of AUC Accumulation Observed (T 1/2eff AUC)
P0C3D1
|
240.671 Hours
Standard Deviation 143.5338
|
742.843 Hours
Standard Deviation NA
insufficient numbers of participants with events
|
547.986 Hours
Standard Deviation NA
insufficient numbers of participants with events
|
428.698 Hours
Standard Deviation 346.4046
|
548.741 Hours
Standard Deviation 78.0213
|
720.317 Hours
Standard Deviation NA
insufficient numbers of participants with events
|
674.755 Hours
Standard Deviation 296.9473
|
|
BMS-986016 Effective Elimination Half-life That Explains the Degree of AUC Accumulation Observed (T 1/2eff AUC)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
638.597 Hours
Standard Deviation NA
insufficient numbers of participants with events
|
524.637 Hours
Standard Deviation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 total body clearance (CL/T). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 = Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=2 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=2 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=1 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=5 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=3 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=12 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Total Body Clearance (CL/T)
P0C3D1
|
28.074 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 6
|
16.333 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 116
|
4.535 mL/h
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
12.777 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75
|
12.974 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 96
|
6.942 mL/h
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
7.819 mL/h
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
|
|
BMS-986016 Total Body Clearance (CL/T)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
6.238 mL/h
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
4.717 mL/h
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 cmax accumulation index (AI\_Cmax). AI is calculated based on ratio of Cmax at steady state to Cmax after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 - Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=2 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=2 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=1 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=7 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=3 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=12 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Cmax Accumulation Index (AI_Cmax)
P0C3D1
|
1.981 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
|
1.701 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 68
|
2.009 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
1.734 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 42
|
2.369 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 12
|
2.573 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
2.139 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28
|
|
BMS-986016 Cmax Accumulation Index (AI_Cmax)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
2.768 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
2.383 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 accumulation index (AI\_AUC). AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 - Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=2 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=2 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=1 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=5 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=3 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=12 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Accumulation Index (AI_AUC)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
3.417 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
2.967 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Accumulation Index (AI_AUC)
P0C3D1
|
1.577 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 34
|
1.850 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 86
|
2.894 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
2.186 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 58
|
2.017 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 50
|
3.647 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
3.268 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 32
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 Ctau accumulation index (AI\_Ctau). AI is calculated based on ratio of Ctau at steady state to Ctau after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 - Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=2 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=2 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=1 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=5 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=3 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=12 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Ctau Accumulation Index (AI_Ctau)
P0C3D1
|
0.743 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =118
|
2.494 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 74
|
4.741 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
2.310 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 68
|
1.686 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 69
|
5.282 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
4.162 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 26
|
|
BMS-986016 Ctau Accumulation Index (AI_Ctau)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
3.344 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
3.558 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 average concentration over a dosing interval (\[AUC(TAU)/tau\] (Css,avg). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 - Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=2 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=2 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=1 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=5 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=3 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=12 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Average Concentration Over a Dosing Interval ([AUC(TAU)/Tau] (Css,Avg)
P0C3D1
|
2.117 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =6
|
14.738 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 116
|
526.269 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
57.790 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85
|
18.345 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64
|
103.805 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
61.385 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46
|
|
BMS-986016 Average Concentration Over a Dosing Interval ([AUC(TAU)/Tau] (Css,Avg)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
120.595 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
109.013 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 15, 29, 43, Cycle 2 Day 1, 15, 29, Cycle 3 Day 1, 15, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, and Cycle 11 Day 1Population: All participants who received at least one dose of BMS-986016 and have evaluable serum concentration data
BMS-986016 trough observed serum concentration (Ctrough). Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. Period 0 = treatment period Period 1 - Re-challenge period
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=7 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=5 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=19 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=48 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C1D15
|
0.064 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =145
|
1.457 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85
|
75.589 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31
|
12.221 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75
|
3.848 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53
|
19.500 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
10.609 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C1D29
|
0.088 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =141
|
4.324 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =78
|
155.896 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 33
|
20.982 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78
|
13.066 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 17
|
32.400 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
18.221 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C1D43
|
—
|
—
|
—
|
—
|
9.435 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 55
|
44.700 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
25.234 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C2D1
|
0.777 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =141
|
6.609 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =75
|
298.666 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43
|
37.013 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 114
|
9.389 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 74
|
59.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
28.428 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C2D15
|
—
|
—
|
—
|
—
|
6.209 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 123
|
62.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
30.218 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 45
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C2D29
|
—
|
—
|
289.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
—
|
26.700 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
70.900 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
36.675 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 50
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C3D1
|
1.020 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
19.018 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =86
|
313.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
16.648 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 121
|
6.867 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 125
|
93.300 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
45.535 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C3D15
|
0.256 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =125
|
2.266 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =140
|
293.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
9.450 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 127
|
9.556 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78
|
103.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
45.685 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 48
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C11D1
|
—
|
—
|
—
|
—
|
—
|
—
|
115.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C5D1
|
0.729 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =45
|
1.917 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =141
|
—
|
18.198 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV =81
|
23.381 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 41
|
149.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
57.068 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 56
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C7D1
|
—
|
59.600 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
—
|
5.760 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
20.264 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70
|
143.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
58.408 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C9D1
|
—
|
62.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
—
|
5.860 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
22.800 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
117.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
56.054 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 62
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P0C11D1
|
—
|
48.100 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
—
|
4.710 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
31.200 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
165.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
67.268 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C1D15
|
—
|
—
|
—
|
—
|
—
|
25.900 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
24.200 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C1D29
|
—
|
—
|
—
|
—
|
—
|
43.600 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
41.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C1D43
|
—
|
—
|
—
|
—
|
—
|
61.800 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
56.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C2D1
|
—
|
—
|
—
|
—
|
—
|
73.800 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
58.700 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C2D15
|
—
|
—
|
—
|
—
|
—
|
84.700 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
69.400 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C2D29
|
—
|
—
|
—
|
—
|
—
|
81.500 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
71.900 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C3D1
|
—
|
—
|
—
|
—
|
—
|
94.600 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
85.500 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C3D15
|
—
|
—
|
—
|
—
|
—
|
86.600 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
86.100 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C5D1
|
—
|
—
|
—
|
—
|
—
|
109.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
70.100 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C7D1
|
—
|
—
|
—
|
—
|
—
|
107.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
105.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
|
BMS-986016 Trough Observed Serum Concentration (Ctrough)
P1C9D1
|
—
|
—
|
—
|
—
|
—
|
115.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
110.000 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants with events
|
SECONDARY outcome
Timeframe: From first dose to 135 days post last dose (Up to 52 months)Population: All BMS-986016 treated participants with baseline and at least one post-baseline assessment
Number of participants with anti-BMS-986016 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is defined as a participant with positive seroconversion detected in the last sample before initiation of treatment. ADA-positive participant is a participant with at least one ADA-positive sample relative to baseline after initiation of the treatment. ADA negative participant is defined as a participant with no ADA positive sample after the initiation of treatment.
Outcome measures
| Measure |
BMS-986016 20mg
n=3 Participants
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
n=7 Participants
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
n=5 Participants
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
n=19 Participants
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=7 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=52 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-BMS-986016 Antibodies (ADA)
ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Anti-BMS-986016 Antibodies (ADA)
Baseline ADA Positive
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Anti-BMS-986016 Antibodies (ADA)
ADA Negative
|
3 Participants
|
7 Participants
|
5 Participants
|
12 Participants
|
4 Participants
|
1 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: From first dose to 135 days post last dose (Up to 52 months)Population: All Nivolumab treated participants with baseline and at least one post-baseline assessment
Number of participants with anti-Nivolumab antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is defined as a participant with positive seroconversion detected in the last sample before initiation of treatment. ADA-positive participant is a participant with at least one ADA-positive sample relative to baseline after initiation of the treatment. ADA negative participant is defined as a participant with no ADA positive sample after the initiation of treatment.
Outcome measures
| Measure |
BMS-986016 20mg
Dose escalation (part A): BMS-986016 20mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg
Dose escalation (part A): BMS-986016 80mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 800mg
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg
Dose escalation (part A) and dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 80mg + Nivolumab
n=4 Participants
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 240mg + Nivolumab
n=1 Participants
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
BMS-986016 160mg + Nivolumab
n=46 Participants
Dose escalation (part C) and dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, until meeting criteria for discontinuation, or clinical deterioration, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Nivolumab Antibodies (ADA)
ADA Negative
|
—
|
—
|
—
|
—
|
4 Participants
|
1 Participants
|
45 Participants
|
|
Number of Participants With Anti-Nivolumab Antibodies (ADA)
Baseline ADA Positive
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Nivolumab Antibodies (ADA)
ADA Positive
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
All Mono Esc 20 Q2W
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
All Mono Esc 80 Q2W
Serious events: 5 serious events
Other events: 9 other events
Deaths: 3 deaths
All Mono Esc 240 Q2W
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
All Mono Esc 800 Q2W
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
CLL BMS-986016 240mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
DLBCL BMS-986016 240mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
iNHL BMS-986016 240mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
HL BMS-986016 240mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
All Combo Esc 80/240 Q2W
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
All Combo Esc 160/240 Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
All Combo Esc 240/240 Q2W
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HL Naive BMS-986016 160mg + Nivolumab
Serious events: 6 serious events
Other events: 20 other events
Deaths: 1 deaths
DLBCL BMS-986016 160mg + Nivolumab
Serious events: 11 serious events
Other events: 11 other events
Deaths: 13 deaths
HL Post I/O BMS-986016 160mg + Nivolumab
Serious events: 9 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All Mono Esc 20 Q2W
n=3 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Mono Esc 80 Q2W
n=9 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Mono Esc 240 Q2W
n=9 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Mono Esc 800 Q2W
n=6 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
CLL BMS-986016 240mg
n=2 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
DLBCL BMS-986016 240mg
n=2 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
iNHL BMS-986016 240mg
n=4 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
HL BMS-986016 240mg
n=3 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Combo Esc 80/240 Q2W
n=7 participants at risk
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Combo Esc 160/240 Q2W
n=4 participants at risk
Dose escalation (part C): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Combo Esc 240/240 Q2W
n=1 participants at risk
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
HL Naive BMS-986016 160mg + Nivolumab
n=21 participants at risk
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
DLBCL BMS-986016 160mg + Nivolumab
n=15 participants at risk
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
HL Post I/O BMS-986016 160mg + Nivolumab
n=20 participants at risk
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Asthenia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Fatigue
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
3/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
2/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
60.0%
9/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Radiculopathy
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
Other adverse events
| Measure |
All Mono Esc 20 Q2W
n=3 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Mono Esc 80 Q2W
n=9 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Mono Esc 240 Q2W
n=9 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Mono Esc 800 Q2W
n=6 participants at risk
Dose escalation (part A): BMS-986016 800mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
CLL BMS-986016 240mg
n=2 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
DLBCL BMS-986016 240mg
n=2 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
iNHL BMS-986016 240mg
n=4 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
HL BMS-986016 240mg
n=3 participants at risk
Dose expansion (part B): BMS-986016 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of BMS-986016 administered on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Combo Esc 80/240 Q2W
n=7 participants at risk
Dose escalation (part C): BMS-986016 IV 80mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Combo Esc 160/240 Q2W
n=4 participants at risk
Dose escalation (part C): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
All Combo Esc 240/240 Q2W
n=1 participants at risk
Dose escalation (part C): BMS-986016 IV 240mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
HL Naive BMS-986016 160mg + Nivolumab
n=21 participants at risk
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
DLBCL BMS-986016 160mg + Nivolumab
n=15 participants at risk
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
HL Post I/O BMS-986016 160mg + Nivolumab
n=20 participants at risk
Dose expansion (part D): BMS-986016 IV 160mg + Nivolumab IV 240mg up to twelve 8-week treatment cycles, confirmed progressive disease, or until meeting criteria for discontinuation, whichever occurs first. Each treatment cycle comprises 4 doses of Nivolumab followed by BMS-986016 on days 1, 15, 29, and 43. Participants could further receive therapy for up to 6 additional eight-week cycles if re-challenge period criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
4/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Anal erythema
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
3/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
2/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
42.9%
3/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
3/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
3/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
42.9%
3/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
23.8%
5/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
44.4%
4/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
4/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
23.8%
5/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Application site reaction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Chills
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Fatigue
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
44.4%
4/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
66.7%
6/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
2/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
66.7%
2/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
38.1%
8/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
26.7%
4/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
40.0%
8/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Malaise
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
3/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
30.0%
6/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
General disorders
Vaccination site reaction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
5/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
2/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
3/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Eye disorders
Eye oedema
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Immune system disorders
Food allergy
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Body tinea
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Candida infection
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Fungal foot infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
6/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
4/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Urinary tract infection
|
66.7%
2/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
3/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Device placement issue
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
3/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
3/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
6/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
75.0%
3/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
6/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Occult blood positive
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
Weight decreased
|
100.0%
3/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
42.9%
3/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
3/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
3/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
23.8%
5/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
3/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
20.0%
4/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
19.0%
4/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Ageusia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
23.8%
5/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
3/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
66.7%
2/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
38.1%
8/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
30.0%
6/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
22.2%
2/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Papule
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
3/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
15.0%
3/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
6.7%
1/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
2/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
42.9%
3/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
38.1%
8/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
28.6%
2/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
9.5%
2/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
10.0%
2/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
16.7%
1/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
66.7%
2/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
50.0%
1/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
25.0%
1/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
5.0%
1/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
33.3%
1/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
13.3%
2/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
100.0%
1/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
11.1%
1/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
4.8%
1/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/9 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/6 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/2 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/3 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
14.3%
1/7 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/4 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/1 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/21 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/15 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
0.00%
0/20 • Serious Adverse Events (SAEs) and Other (Not including Serious) Adverse Events (AEs) are collected from first dose to 135 days post last dose (Up to 52 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 95 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER