Trial Outcomes & Findings for A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (NCT NCT04497844)
NCT ID: NCT04497844
Last Updated: 2026-01-22
Results Overview
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
696 participants
Primary outcome timeframe
From date of randomization (Day -3 to Day 1) up to approximately 49 months
Results posted on
2026-01-22
Participant Flow
The results presented are based on the primary completion date (07 January 2025). Remaining results will be reported within a year of study completion.
Participant milestones
| Measure |
Placebo With Abiraterone Acetate Plus Prednisone
Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
Niraparib With Abiraterone Acetate Plus Prednisone
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
348
|
348
|
|
Overall Study
Treated
|
348
|
347
|
|
Overall Study
BRCA Subgroup
|
196
|
191
|
|
Overall Study
HRR Effector Subgroup
|
226
|
230
|
|
Overall Study
All HRR
|
348
|
348
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
348
|
348
|
Reasons for withdrawal
| Measure |
Placebo With Abiraterone Acetate Plus Prednisone
Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
Niraparib With Abiraterone Acetate Plus Prednisone
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
Overall Study
Ongoing
|
231
|
249
|
|
Overall Study
Death
|
106
|
84
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
14
|
|
Overall Study
Regional Crisis
|
3
|
1
|
Baseline Characteristics
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Baseline characteristics by cohort
| Measure |
Placebo With Abiraterone Acetate Plus Prednisone
n=348 Participants
Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
Niraparib With Abiraterone Acetate Plus Prednisone
n=348 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
Total
n=696 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 8.84 • n=270 Participants
|
67.8 years
STANDARD_DEVIATION 8.75 • n=4 Participants
|
67.3 years
STANDARD_DEVIATION 8.81 • n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
348 Participants
n=270 Participants
|
348 Participants
n=4 Participants
|
696 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=270 Participants
|
40 Participants
n=4 Participants
|
83 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
292 Participants
n=270 Participants
|
287 Participants
n=4 Participants
|
579 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=270 Participants
|
21 Participants
n=4 Participants
|
34 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
67 Participants
n=270 Participants
|
77 Participants
n=4 Participants
|
144 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=270 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
257 Participants
n=270 Participants
|
246 Participants
n=4 Participants
|
503 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=9 Participants
|
|
Age, Categorical
Adults (18-64 years)
|
135 Participants
n=270 Participants
|
116 Participants
n=4 Participants
|
251 Participants
n=9 Participants
|
|
Age, Categorical
From 65 to 84 years
|
212 Participants
n=270 Participants
|
227 Participants
n=4 Participants
|
439 Participants
n=9 Participants
|
|
Age, Categorical
85 years and over
|
1 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
ARGENTINA
|
15 Participants
n=270 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=9 Participants
|
|
Region of Enrollment
AUSTRALIA
|
9 Participants
n=270 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=9 Participants
|
|
Region of Enrollment
BELARUS
|
6 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Region of Enrollment
BELGIUM
|
4 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Region of Enrollment
BRAZIL
|
30 Participants
n=270 Participants
|
28 Participants
n=4 Participants
|
58 Participants
n=9 Participants
|
|
Region of Enrollment
BULGARIA
|
3 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
CANADA
|
14 Participants
n=270 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=9 Participants
|
|
Region of Enrollment
CHINA
|
24 Participants
n=270 Participants
|
29 Participants
n=4 Participants
|
53 Participants
n=9 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
3 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
DENMARK
|
6 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
|
Region of Enrollment
FRANCE
|
17 Participants
n=270 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=9 Participants
|
|
Region of Enrollment
GERMANY
|
6 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=9 Participants
|
|
Region of Enrollment
HUNGARY
|
4 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Region of Enrollment
ISRAEL
|
3 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=9 Participants
|
|
Region of Enrollment
ITALY
|
32 Participants
n=270 Participants
|
24 Participants
n=4 Participants
|
56 Participants
n=9 Participants
|
|
Region of Enrollment
MALAYSIA
|
4 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=9 Participants
|
|
Region of Enrollment
MEXICO
|
3 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=9 Participants
|
|
Region of Enrollment
NETHERLANDS
|
2 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
NEW ZEALAND
|
6 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Region of Enrollment
POLAND
|
12 Participants
n=270 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=9 Participants
|
|
Region of Enrollment
PORTUGAL
|
1 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
11 Participants
n=270 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=9 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
1 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
20 Participants
n=270 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=9 Participants
|
|
Region of Enrollment
SPAIN
|
18 Participants
n=270 Participants
|
21 Participants
n=4 Participants
|
39 Participants
n=9 Participants
|
|
Region of Enrollment
SWEDEN
|
2 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
TAIWAN
|
11 Participants
n=270 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=9 Participants
|
|
Region of Enrollment
THAILAND
|
4 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Region of Enrollment
TURKEY
|
24 Participants
n=270 Participants
|
21 Participants
n=4 Participants
|
45 Participants
n=9 Participants
|
|
Region of Enrollment
UKRAINE
|
12 Participants
n=270 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=9 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
11 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=9 Participants
|
|
Region of Enrollment
UNITED STATES
|
30 Participants
n=270 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to approximately 49 monthsPopulation: BRCA full analysis set (FAS) included all randomized participants with BRCA gene alteration classified according to their assigned treatment arm, regardless of the actual treatment received.
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.
Outcome measures
| Measure |
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
n=196 Participants
Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and AA fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
n=191 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
|
25.99 months
Interval 22.11 to 41.17
|
NA months
Interval 41.2 to
Median and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to approximately 49 monthsPopulation: HRR effector FAS included all randomized HRR effector participants classified according to their assigned treatment arm, regardless of the actual treatment received.
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan \>= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.
Outcome measures
| Measure |
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
n=226 Participants
Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and AA fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
n=230 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
|
27.56 months
Interval 25.59 to
The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
|
NA months
Interval 41.2 to
Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to approximately 49 monthsPopulation: All HRR FAS included all randomized participants classified according to their assigned treatment arm, regardless of the actual treatment received.
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan \>= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.
Outcome measures
| Measure |
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
n=348 Participants
Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and AA fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
n=348 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
|
29.54 months
Interval 25.82 to
The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
|
NA months
Interval 41.2 to
Median and the upper limit of the 95% CI were not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to approximately 49 monthsPopulation: BRCA FAS included all randomized participants with BRCA gene alteration classified according to their assigned treatment arm, regardless of the actual treatment received.
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture \[symptomatic and/or pathologic\], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Outcome measures
| Measure |
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
n=196 Participants
Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and AA fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
n=191 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
BRCA Subgroup: Time to Symptomatic Progression
|
NA months
Interval 39.72 to
Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
NA months
Median, lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to approximately 49 monthsPopulation: HRR effector FAS included all randomized HRR effector participants classified according to their assigned treatment arm, regardless of the actual treatment received.
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture \[symptomatic and/or pathologic\], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Outcome measures
| Measure |
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
n=226 Participants
Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and AA fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
n=230 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
HRR Effector Subgroup: Time to Symptomatic Progression
|
NA months
Median, lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
NA months
Interval 41.4 to
Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to approximately 49 monthsPopulation: All HRR FAS included all randomized participants classified according to their assigned treatment arm, regardless of the actual treatment received.
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture \[symptomatic and/or pathologic\], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Outcome measures
| Measure |
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
n=348 Participants
Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and AA fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
n=348 Participants
Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
All HRR: Time to Symptomatic Progression
|
NA months
Interval 43.14 to
Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
NA months
Median, lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to 83 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization (Day -3 to Day 1) up to 83 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to 83 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 up to 83 monthsOutcome measures
Outcome data not reported
Adverse Events
Placebo With Abiraterone Acetate Plus Prednisone
Serious events: 96 serious events
Other events: 326 other events
Deaths: 108 deaths
Niraparib With Abiraterone Acetate Plus Prednisone
Serious events: 136 serious events
Other events: 338 other events
Deaths: 85 deaths
Serious adverse events
| Measure |
Placebo With Abiraterone Acetate Plus Prednisone
n=348 participants at risk
Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
Niraparib With Abiraterone Acetate Plus Prednisone
n=347 participants at risk
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
4/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
5.8%
20/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina Pectoris
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina Unstable
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac Arrest
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac Failure
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
1.2%
4/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial Infarction
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric Stenosis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Proctalgia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
General Physical Health Deterioration
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Sudden Death
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Immune system disorders
Allergy to Arthropod Sting
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Alpha Haemolytic Streptococcal Infection
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Covid-19
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Metapneumovirus Pneumonia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Necrotising Fasciitis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Periodontitis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
2.9%
10/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
3.5%
12/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia Influenzal
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Psoas Abscess
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pulmonary Sepsis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
1.4%
5/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Septic Shock
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
6/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
2.6%
9/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Bladder Injury
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
1.2%
4/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Urinary Tract Stoma Complication
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Urostomy Complication
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.86%
3/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic Ketosis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
2.3%
8/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
1.2%
4/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
1.1%
4/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma Stage Iii
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Gastric Cancer
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Tumour of the Lung
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular Neoplasm
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Cystadenoma Lymphomatosum
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Basal Ganglia Infarction
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral Artery Occlusion
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral Venous Sinus Thrombosis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Hypoglycaemic Encephalopathy
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Nervous System Disorder
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraparesis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Spinal Cord Compression
|
1.1%
4/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mania
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.1%
4/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
1.7%
6/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Bladder Outlet Obstruction
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Bladder Tamponade
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
5/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
1.2%
4/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Lower Urinary Tract Symptoms
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary Retention
|
0.86%
3/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.58%
2/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Essential Hypertension
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.29%
1/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
0.29%
1/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo With Abiraterone Acetate Plus Prednisone
n=348 participants at risk
Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
Niraparib With Abiraterone Acetate Plus Prednisone
n=347 participants at risk
Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.0%
14/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
6.1%
21/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
57/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
35.2%
122/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
40/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
14.7%
51/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.0%
14/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
6.3%
22/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
20/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
7.8%
27/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
14.4%
50/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
30.8%
107/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.5%
26/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
8.1%
28/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
30/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
16.1%
56/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
23.9%
83/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
51.3%
178/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.2%
18/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
16.7%
58/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.5%
26/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
13.0%
45/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
28/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
21.3%
74/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
20/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
19.0%
66/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.57%
2/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
6.1%
21/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
12.6%
44/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
13.5%
47/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
18.4%
64/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
26.2%
91/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Oedema Peripheral
|
12.1%
42/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
15.9%
55/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
6.3%
22/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
8.4%
29/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Covid-19
|
20.1%
70/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
17.9%
62/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.9%
17/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
9.8%
34/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
9.8%
34/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
10.1%
35/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
8.9%
31/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
7.5%
26/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Alanine Aminotransferase Increased
|
15.5%
54/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
6.3%
22/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Aspartate Aminotransferase Increased
|
14.4%
50/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
8.1%
28/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
6.3%
22/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
4.0%
14/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Blood Creatinine Increased
|
4.6%
16/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
12.7%
44/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Weight Decreased
|
5.2%
18/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
15.3%
53/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Weight Increased
|
11.2%
39/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
3.5%
12/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.2%
18/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
14.7%
51/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.1%
42/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
13.8%
48/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.8%
69/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
25.1%
87/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.3%
74/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
21.0%
73/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
21.8%
76/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
19.0%
66/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.8%
27/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
5.2%
18/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.2%
25/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
5.5%
19/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.2%
39/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
8.9%
31/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
9.2%
32/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
14.4%
50/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
9.8%
34/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
13.5%
47/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
7.8%
27/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
14.1%
49/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
6.0%
21/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
4.3%
15/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
6.0%
21/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
6.3%
22/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
6.9%
24/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
4.6%
16/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
40/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
11.0%
38/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
20/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
13.0%
45/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hot Flush
|
13.8%
48/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
18.2%
63/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
32.5%
113/348 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
43.8%
152/347 • All cause mortality: From screening (Day -38 up to Day -1) up to approximately 49 months. Serious adverse events (SAEs) and other AEs: From Cycle 1 Day 1 up to approximately 49 months
All cause mortality: All randomized participants; SAE and Other AEs: The safety analysis set included all randomized participants who received at least 1 dose of study medication.
|
Additional Information
Executive Director Clinical Prostate
Janssen Research and Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER