Trial Outcomes & Findings for A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT03038100)
NCT ID: NCT03038100
Last Updated: 2023-02-17
Results Overview
Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
COMPLETED
PHASE3
1301 participants
From randomization until disease progression or death from any cause (up to approximately 55 months)
2023-02-17
Participant Flow
The study is considered "Completed" because all pre-planned study activities and analyses have been performed.
Participant milestones
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
650
|
651
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
650
|
651
|
Reasons for withdrawal
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Overall Study
Death
|
289
|
272
|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
|
Overall Study
Protocol Deviation
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
45
|
51
|
|
Overall Study
Study Terminated By Sponsor
|
305
|
311
|
|
Overall Study
Physician Decision
|
1
|
3
|
Baseline Characteristics
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=650 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=651 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
Total
n=1301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
59.1 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
650 Participants
n=5 Participants
|
651 Participants
n=7 Participants
|
1301 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
598 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
1187 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
155 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
461 Participants
n=5 Participants
|
464 Participants
n=7 Participants
|
925 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression or death from any cause (up to approximately 55 months)Population: Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.
Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=650 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=651 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population
|
18.37 Months
Interval 17.22 to 19.75
|
19.48 Months
Interval 18.14 to 20.76
|
PRIMARY outcome
Timeframe: From randomization until disease progression or death from any cause (up to approximately 55 months)Population: PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.
Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=393 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=391 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
|
18.50 Months
Interval 16.62 to 21.36
|
20.83 Months
Interval 19.06 to 24.21
|
PRIMARY outcome
Timeframe: From randomization up to death from any cause (up to approximately 59 months)Population: Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.
Overall Survival (OS) is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=650 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=651 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Overall Survival - ITT Population
|
46.59 Months
Interval 45.31 to 49.74
|
50.53 Months
Interval 46.26 to
The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
|
PRIMARY outcome
Timeframe: From randomization up to death from any cause (up to approximately 59 months)Population: PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.
Overall Survival (OS) is defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=393 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=391 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Overall Survival - PD-L1-Positive Subpopulation
|
49.15 Months
Interval 45.54 to
The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
|
NA Months
67.3% of the participants were censored and the median was not reached.
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death from any cause (up to approximately 55 months)Population: Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.
OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=650 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=651 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
|
88.7 Percentage of participants
|
92.8 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization until disease progression or death from any cause (up to approximately 55 months)Population: Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.
OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=393 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=391 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population
|
89.9 Percentage of participants
|
92.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)Population: Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.
DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=650 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=651 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
|
14.06 Months
Interval 13.01 to 16.62
|
16.59 Months
Interval 14.52 to 19.09
|
SECONDARY outcome
Timeframe: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)Population: Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The PD-L1-positive subpopulation (defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization) who underwent primary tumor-reductive surgery.
DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=142 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=156 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population
|
13.44 Months
Interval 12.71 to 19.29
|
17.71 Months
Interval 15.01 to 19.61
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.Population: Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.
Clinically-meaningful improvement defined as a \>=10-point decrease from the baseline score in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=157 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=152 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Presurgical/Surgery
|
54.2 Percentage of participants
|
50.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Cycle 4 Day 1
|
36.4 Percentage of participants
|
32.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Cycle 6 Day 1
|
55.0 Percentage of participants
|
48.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Cycle 16 Day 1
|
63.5 Percentage of participants
|
58.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Completion of Treatment/Early Termination Visit
|
51.0 Percentage of participants
|
51.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Post-Treatment Follow Up 3 Months
|
58.3 Percentage of participants
|
51.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Presurgical/Surgery
|
62.7 Percentage of participants
|
54.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Cycle 4 Day 1
|
65.0 Percentage of participants
|
59.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Cycle 16 Day 1
|
66.7 Percentage of participants
|
64.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Cycle 20 Day 1
|
66.3 Percentage of participants
|
56.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Completion of Treatment/ Early Termination Visit
|
62.1 Percentage of participants
|
58.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Post-Treatment Follow Up 3 Months
|
57.3 Percentage of participants
|
53.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Cycle 8 Day 1
|
64.3 Percentage of participants
|
54.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Cycle 12 Day 1
|
63.1 Percentage of participants
|
57.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Cycle 20 Day 1
|
68.7 Percentage of participants
|
48.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Post-Treatment Follow Up 6 Months
|
61.3 Percentage of participants
|
51.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Post-Treatment Follow Up 9 Months
|
60.5 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Post-Treatment Follow Up 12 Months
|
70.6 Percentage of participants
|
58.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Post-Treatment Follow Up 18 Months
|
100 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Abdominal Pain, Post-Treatment Follow Up 24 Months
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Cycle 6 Day 1
|
71.0 Percentage of participants
|
66.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Cycle 8 Day 1
|
71.9 Percentage of participants
|
63.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Cycle 12 Day 1
|
68.5 Percentage of participants
|
63.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Post-Treatment Follow Up 6 Months
|
59.2 Percentage of participants
|
62.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Post-Treatment Follow Up 9 Months
|
67.4 Percentage of participants
|
63.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Post-Treatment Follow Up 12 Months
|
47.1 Percentage of participants
|
62.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Post-Treatment Follow Up 18 Months
|
66.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Bloating, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.Population: PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a \>=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=157 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=152 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Post-Treatment Follow Up 12 Months
|
23.5 Percentage of participants
|
54.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Cycle 6 Day 1
|
35.6 Percentage of participants
|
25.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Cycle 8 Day 1
|
37.2 Percentage of participants
|
36.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Cycle 16 Day 1
|
42.7 Percentage of participants
|
42.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Completion of Treatment/Early Termination Visit
|
38.9 Percentage of participants
|
34.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Post-Treatment Follow Up 9 Months
|
32.6 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Post-Treatment Follow Up 12 Months
|
23.5 Percentage of participants
|
37.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Cycle 8 Day 1
|
50.4 Percentage of participants
|
39.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Post-Treatment Follow Up 18 Months
|
66.7 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Cycle 16 Day 1
|
44.8 Percentage of participants
|
42.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Post-Treatment Follow Up 9 months
|
39.5 Percentage of participants
|
34.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Post-Treatment Follow Up 12 months
|
29.4 Percentage of participants
|
29.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, PresurgicalSurgery
|
44.4 Percentage of participants
|
46.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Cycle 6 Day 1
|
51.1 Percentage of participants
|
47.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Cycle 12 Day 1
|
45.9 Percentage of participants
|
43.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Cycle 20 Day 1
|
41.0 Percentage of participants
|
31.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Post-Treatment Follow Up 3 Months
|
37.1 Percentage of participants
|
39.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Presurgical/Surgery
|
35.9 Percentage of participants
|
33.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Cycle 4 Day 1
|
28.4 Percentage of participants
|
18.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Post-Treatment Follow Up 6 Months
|
40.8 Percentage of participants
|
39.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Post-Treatment Follow Up 18 Months
|
33.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Physical Functioning, Post-Treatment Follow Up 24 Months
|
100 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Presurgical/Surgery
|
48.6 Percentage of participants
|
40.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Cycle 4 Day 1
|
38.3 Percentage of participants
|
22.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Cycle 6 Day 1
|
45.9 Percentage of participants
|
33.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Cycle 12 Day 1
|
55.9 Percentage of participants
|
47.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Cycle 16 Day 1
|
53.1 Percentage of participants
|
46.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Cycle 20 Day 1
|
56.6 Percentage of participants
|
52.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Completion of Treatment/ Early Termination Visit
|
46.9 Percentage of participants
|
39.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Post-Treatment Follow Up 3 Months
|
49.5 Percentage of participants
|
40.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Post-Treatment Follow Up 6 Months
|
51.3 Percentage of participants
|
48.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Post-Treatment Follow Up 9 Months
|
53.5 Percentage of participants
|
52.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Post-Treatment Follow Up 18 Months
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Role Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Presurgical/Surgery
|
32.4 Percentage of participants
|
33.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Cycle 4 Day 1
|
31.2 Percentage of participants
|
25.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Cycle 6 Day 1
|
36.8 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Cycle 8 Day 1
|
40.3 Percentage of participants
|
39.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Cycle 12 Day 1
|
39.6 Percentage of participants
|
44.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Cycle 16 Day 1
|
40.0 Percentage of participants
|
44.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Cycle 20 Day 1
|
45.8 Percentage of participants
|
43.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Completion of Treatment/Early Termination
|
40.3 Percentage of participants
|
41.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Post-Treatment Follow Up 3 Months
|
42.7 Percentage of participants
|
44.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Post-Treatment Follow Up 6 Months
|
46.1 Percentage of participants
|
35.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Post-Treatment Follow Up 9 Months
|
46.5 Percentage of participants
|
47.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Social Functioning, Post-Treatment Follow Up 12 Months
|
29.4 Percentage of participants
|
54.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Presurgical/Surgery
|
31.7 Percentage of participants
|
30.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Cycle 4 Day 1
|
31.2 Percentage of participants
|
35.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Cycle 6 Day 1
|
42.1 Percentage of participants
|
38.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Cycle 8 Day 1
|
39.5 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Cycle 12 Day 1
|
41.4 Percentage of participants
|
41.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Cycle 20 Day 1
|
44.6 Percentage of participants
|
32.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Completion of Treatment/Early Termination Visit
|
33.8 Percentage of participants
|
33.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Post-Treatment Follow Up 3 months
|
35.4 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Post-Treatment Follow Up 6 months
|
30.3 Percentage of participants
|
33.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Post-Treatment Follow Up 18 months
|
16.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Emotional Functioning, Post-Treatment Follow Up 24 months
|
0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Cycle 4 Day 1
|
43.3 Percentage of participants
|
37.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Cycle 8 Day 1
|
55.0 Percentage of participants
|
59.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Cycle 12 Day 1
|
60.4 Percentage of participants
|
61.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Cycle 16 Day 1
|
53.1 Percentage of participants
|
58.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Cycle 20 Day 1
|
59.0 Percentage of participants
|
61.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Completion of Treatment/ Early Termination Visit
|
46.9 Percentage of participants
|
53.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Post-Treatment Follow Up 3 Months
|
53.7 Percentage of participants
|
53.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Post-Treatment Follow Up 6 Months
|
48.7 Percentage of participants
|
41.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Post-Treatment Follow Up 9 Months
|
39.5 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Post-Treatment Follow Up 12 Months
|
17.6 Percentage of participants
|
41.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
GHS/HRQoL, Post-Treatment Follow Up 18 Months
|
16.7 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.Population: PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
Percentage of participants with clinical improvement, defined as \>= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=473 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=473 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
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Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 16 Day 1
|
32.1 Percentage of participants
|
34.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 5 Day 1
|
42.9 Percentage of participants
|
38.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 3 Months
|
42.7 Percentage of participants
|
41.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 20 Day 1
|
35.3 Percentage of participants
|
36.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 6 Months
|
39.2 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 9 Months
|
39.3 Percentage of participants
|
35.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 3 Day 1
|
22.6 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 5 Day 1
|
23.7 Percentage of participants
|
21.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 8 Day 1
|
28.7 Percentage of participants
|
27.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 12 Day 1
|
35.4 Percentage of participants
|
32.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 20 Day 1
|
34.8 Percentage of participants
|
32.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Completion of Treatment/Early Termination Visit
|
32.4 Percentage of participants
|
30.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 3 Months
|
35.7 Percentage of participants
|
28.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 6 Months
|
32.7 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 9 Months
|
34.5 Percentage of participants
|
27.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 12 Months
|
37.8 Percentage of participants
|
24.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 18 Months
|
42.9 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 3 Day 1
|
42.6 Percentage of participants
|
40.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 8 Day 1
|
47.5 Percentage of participants
|
45.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 12 Day 1
|
50.1 Percentage of participants
|
50.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 16 Day 1
|
52.0 Percentage of participants
|
50.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 20 Day 1
|
53.8 Percentage of participants
|
51.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Completion of Treatment/ Early Termination Visit
|
48.4 Percentage of participants
|
46.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 3 Months
|
54.0 Percentage of participants
|
45.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 6 Months
|
55.1 Percentage of participants
|
43.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 9 Months
|
57.1 Percentage of participants
|
38.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 12 Months
|
60 Percentage of participants
|
27.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 18 Months
|
50 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 24 Months
|
50 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 3 Day 1
|
30.1 Percentage of participants
|
31.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 5 Day 1
|
32.6 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 8 Day 1
|
37.8 Percentage of participants
|
38.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 12 Day 1
|
42.6 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 16 Day 1
|
43.5 Percentage of participants
|
48.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 20 Day 1
|
45.6 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Completion of Treatment/ Early Termination Visit
|
40.6 Percentage of participants
|
40.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 6 Months
|
43.2 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 9 Months
|
50.0 Percentage of participants
|
36.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 12 Months
|
62.2 Percentage of participants
|
36.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 18 Months
|
57.1 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 24 Months
|
100 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 3 Day 1
|
29.7 Percentage of participants
|
28.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 5 Day 1
|
30.3 Percentage of participants
|
30.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 8 Day 1
|
32.3 Percentage of participants
|
33.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 12 Day 1
|
34.6 Percentage of participants
|
36.1 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 16 Day 1
|
31.8 Percentage of participants
|
35.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Completion of Treatment/ Early Termination Visit
|
27.7 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 3 Months
|
29.1 Percentage of participants
|
27.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 6 Months
|
30.4 Percentage of participants
|
37.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 9 Months
|
38.1 Percentage of participants
|
33.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 12 Months
|
44.4 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 18 Months
|
42.9 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 24 Months
|
50.0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 3 Day 1
|
32.3 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 5 Day 1
|
33.0 Percentage of participants
|
31.0 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 8 Day 1
|
39.5 Percentage of participants
|
38.7 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 12 Day 1
|
41.5 Percentage of participants
|
43.4 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 16 Day 1
|
42.9 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 20 Day 1
|
42.5 Percentage of participants
|
46.2 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Completion of Treatment/ Early Termination Visit
|
38.0 Percentage of participants
|
34.9 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 3 Months
|
40.6 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 12 Months
|
40.0 Percentage of participants
|
32.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 18 Months
|
42.9 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 24 Months
|
100 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.Population: PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=473 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=473 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 9 Months
|
46.4 Percentage of participants
|
46.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 12 Months
|
44.4 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 5 Day 1
|
30.1 Percentage of participants
|
33.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 8 Day 1
|
31.2 Percentage of participants
|
30.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 12 Day 1
|
32.9 Percentage of participants
|
32.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 20 Day 1
|
27.3 Percentage of participants
|
34.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 18 Months
|
42.9 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 5 Day 1
|
37.6 Percentage of participants
|
36.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 8 Day 1
|
40.2 Percentage of participants
|
35.2 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 12 Day 1
|
38.3 Percentage of participants
|
39.2 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 9 Months
|
53.6 Percentage of participants
|
48.0 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 12 Months
|
46.7 Percentage of participants
|
43.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 18 Months
|
50.0 Percentage of participants
|
37.5 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 12 Day 1
|
40.7 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 16 Day 1
|
38.4 Percentage of participants
|
43.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 20 Day 1
|
36.9 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Completion of Treatment/ Early Termination Visit
|
37.2 Percentage of participants
|
40.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 3 Months
|
38.9 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 6 Months
|
39.9 Percentage of participants
|
42.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 9 Months
|
39.3 Percentage of participants
|
38.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 12 Months
|
42.2 Percentage of participants
|
32.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 18 Months
|
35.7 Percentage of participants
|
37.5 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 3 Day 1
|
53.1 Percentage of participants
|
56.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 5 Day 1
|
49.0 Percentage of participants
|
50.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 8 Day 1
|
47.8 Percentage of participants
|
49.4 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 12 Day 1
|
47.1 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 16 Day 1
|
50.5 Percentage of participants
|
48.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 20 Day 1
|
46.6 Percentage of participants
|
50.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Completion of Treatment/ Early Termination Visit
|
46.8 Percentage of participants
|
44.5 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 3 Months
|
41.3 Percentage of participants
|
47.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 6 Months
|
42.2 Percentage of participants
|
43.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 18 Months
|
35.7 Percentage of participants
|
56.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 24 Months
|
100 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 3 Day 1
|
35.8 Percentage of participants
|
30.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 16 Day 1
|
27.6 Percentage of participants
|
33.4 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Completion of Treatment/ Early Termination Visit
|
28.6 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 3 Months
|
25.1 Percentage of participants
|
27.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 6 Months
|
24.5 Percentage of participants
|
29.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 9 Months
|
23.8 Percentage of participants
|
34.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 12 Months
|
33.3 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 24 Months
|
50 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 3 Day 1
|
40.7 Percentage of participants
|
36.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 16 Day 1
|
36.6 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 20 Day 1
|
34.1 Percentage of participants
|
33.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Completion of Treatment/ Early Termination Visit
|
31.9 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 3 Months
|
30.3 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 6 Months
|
33.8 Percentage of participants
|
34.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 9 Months
|
27.4 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 12 Months
|
28.9 Percentage of participants
|
25.9 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 18 Months
|
28.6 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 3 Day 1
|
57.5 Percentage of participants
|
57.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 5 Day 1
|
52.4 Percentage of participants
|
53.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 8 Day 1
|
53.2 Percentage of participants
|
54.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 12 Day 1
|
53.2 Percentage of participants
|
50.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 16 Day 1
|
55.0 Percentage of participants
|
51.3 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 20 Day 1
|
49.2 Percentage of participants
|
52.1 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Completion of Treatment/ Early Termination Visit
|
53.0 Percentage of participants
|
51.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 3 Months
|
51.3 Percentage of participants
|
55.5 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 6 Months
|
48.6 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 24 Months
|
50.0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 3 Day 1
|
43.3 Percentage of participants
|
42.2 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 5 Day 1
|
42.6 Percentage of participants
|
44.8 Percentage of participants
|
|
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL, Cycle 8 Day 1
|
39.0 Percentage of participants
|
42.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.Population: PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
Percentage of participants with deterioration in patient-reported function and HRQoL, defined as \>= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=473 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=473 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 6 Months
|
24.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 9 Months
|
19.0 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 12 Months
|
17.8 Percentage of participants
|
25.9 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 18 Months
|
21.4 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
50 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 3 Day 1
|
21.3 Percentage of participants
|
27.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 5 Day 1
|
26.7 Percentage of participants
|
27.0 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 8 Day 1
|
21.1 Percentage of participants
|
22.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 12 Day 1
|
16.7 Percentage of participants
|
16.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 3 Day 1
|
24.1 Percentage of participants
|
24.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 5 Day 1
|
27.1 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 8 Day 1
|
23.4 Percentage of participants
|
23.6 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 12 Day 1
|
17.2 Percentage of participants
|
16.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 16 Day 1
|
17.1 Percentage of participants
|
17.0 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Cycle 20 Day 1
|
18.2 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Completion of Treatment/ Early Termination Visit
|
20.5 Percentage of participants
|
25.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Physical Functioning, Post-Treatment Follow Up 3 Months
|
22.6 Percentage of participants
|
23.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 16 Day 1
|
20.1 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Completion of Treatment/ Early Termination Visit
|
23.0 Percentage of participants
|
24.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 3 Months
|
20.9 Percentage of participants
|
27.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 6 Months
|
20.4 Percentage of participants
|
25.6 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 9 Months
|
19.0 Percentage of participants
|
26.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 12 Months
|
6.7 Percentage of participants
|
37.9 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 18 Months
|
7.1 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 3 Day 1
|
29.0 Percentage of participants
|
31.2 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 5 Day 1
|
29.6 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 8 Day 1
|
21.8 Percentage of participants
|
25.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 12 Day 1
|
18.9 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 16 Day 1
|
19.5 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Cycle 20 Day 1
|
20.2 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Completion of Treatment/ Early Termination Visit
|
27.2 Percentage of participants
|
28.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 3 Months
|
26.5 Percentage of participants
|
25.4 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 6 Months
|
23.0 Percentage of participants
|
30.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 9 Months
|
22.6 Percentage of participants
|
32.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 12 Months
|
8.9 Percentage of participants
|
37.9 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 18 Months
|
14.3 Percentage of participants
|
37.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Social Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 3 Day 1
|
12.8 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 5 Day 1
|
17.3 Percentage of participants
|
15.9 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 8 Day 1
|
14.6 Percentage of participants
|
12.4 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 16 Day 1
|
13.2 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 20 Day 1
|
15.5 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Completion of Treatment/ Early Termination Visit
|
19.3 Percentage of participants
|
19.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 9 Months
|
8.3 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Cycle 3 Day 1
|
24.2 Percentage of participants
|
22.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Cycle 8 Day 1
|
21.3 Percentage of participants
|
18.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Post-Treatment Follow Up 3 Months
|
20.5 Percentage of participants
|
22.9 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Post-Treatment Follow Up 18 Months
|
21.4 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Role Functioning, Cycle 20 Day 1
|
18.6 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Cycle 12 Day 1
|
12.2 Percentage of participants
|
13.4 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 3 Months
|
19.7 Percentage of participants
|
16.9 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 6 Months
|
20.9 Percentage of participants
|
14.6 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 12 Months
|
8.9 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 18 Months
|
7.1 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Emotional Functioning, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Cycle 5 Day 1
|
24.1 Percentage of participants
|
23.7 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Cycle 12 Day 1
|
17.6 Percentage of participants
|
13.2 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Cycle 16 Day 1
|
18.3 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Cycle 20 Day 1
|
20.2 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Completion of Treatment/ Early Termination Visit
|
24.5 Percentage of participants
|
24.3 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Post-Treatment Follow Up 6 Months
|
20.9 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Post-Treatment Follow Up 9 Months
|
21.4 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Post-Treatment Follow Up 12 Months
|
17.8 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
GHS/OoL Function, Post-Treatment Follow Up 24 Months
|
0 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization up to approximately 59 monthsPopulation: Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).
Percentage of participants with at least one adverse event.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=644 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=642 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event
|
99.8 Percentage
|
100 Percentage
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dosePopulation: PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=538 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
Cycle 1 Day 1
|
487 µg/mL
Standard Deviation 163
|
—
|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
Cycle 3 Day 1
|
614 µg/mL
Standard Deviation 209
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predosePopulation: PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=532 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 2 Day 1
|
88.9 µg/mL
Standard Deviation 35.8
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 3 Day 1
|
146 µg/mL
Standard Deviation 93.0
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 4 Day 1
|
149 µg/mL
Standard Deviation 88.1
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 8 Day 1
|
242 µg/mL
Standard Deviation 96.3
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 16 Day 1
|
286 µg/mL
Standard Deviation 111
|
—
|
SECONDARY outcome
Timeframe: Baseline to approximately 55 monthsPopulation: PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
Outcome measures
| Measure |
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=569 Participants
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
|
|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Baseline evaluable participants
|
0.7 Percentage of participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Post-baseline evaluable participants
|
22.7 Percentage of participants
|
—
|
Adverse Events
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Serious adverse events
| Measure |
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=642 participants at risk
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=644 participants at risk
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
|---|---|---|
|
Injury, poisoning and procedural complications
FALL
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FASCIAL RUPTURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
AGRANULOCYTOSIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.93%
6/642 • Number of events 7 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.6%
10/644 • Number of events 10 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
8.4%
54/642 • Number of events 59 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.7%
24/644 • Number of events 25 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
GRANULOCYTOSIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
IMMUNE THROMBOCYTOPENIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.78%
5/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.78%
5/644 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.2%
8/642 • Number of events 11 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.6%
10/644 • Number of events 12 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
THROMBOTIC MICROANGIOPATHY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ATRIAL THROMBOSIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
MYOCARDITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Cardiac disorders
PALPITATIONS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Ear and labyrinth disorders
OTOLITHIASIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
ADDISON'S DISEASE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
SECONDARY ADRENOCORTICAL INSUFFICIENCY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Eye disorders
OCULAR MYASTHENIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Eye disorders
OPTIC NEUROPATHY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Eye disorders
ULCERATIVE KERATITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.4%
9/642 • Number of events 9 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.16%
1/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
COLITIS
|
1.7%
11/642 • Number of events 12 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.93%
6/644 • Number of events 6 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.78%
5/644 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.4%
9/642 • Number of events 11 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.7%
11/644 • Number of events 13 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DUODENAL PERFORATION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.62%
4/644 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTRIC STENOSIS
|
0.16%
1/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ILEUS
|
1.9%
12/642 • Number of events 14 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.2%
8/644 • Number of events 10 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INCARCERATED INGUINAL HERNIA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INCARCERATED UMBILICAL HERNIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.2%
8/642 • Number of events 8 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
7/644 • Number of events 9 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINAL HAEMORRHAGE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
MECHANICAL ILEUS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.78%
5/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.78%
5/644 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ORAL LICHEN PLANUS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
PANCREATIC FISTULA
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
PERITONEAL ADHESIONS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
PNEUMATOSIS INTESTINALIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.6%
10/642 • Number of events 11 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.93%
6/644 • Number of events 6 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
THROMBOSIS MESENTERIC VESSEL
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.62%
4/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
7/644 • Number of events 8 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
ASTHENIA
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
CONDITION AGGRAVATED
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
DEATH
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
DEVICE RELATED THROMBOSIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
EARLY SATIETY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
FATIGUE
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.47%
3/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PAIN
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PYREXIA
|
4.0%
26/642 • Number of events 31 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.2%
8/644 • Number of events 9 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
IMMUNE-MEDIATED HEPATITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
LIVER INJURY
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
CYTOKINE RELEASE SYNDROME
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
IMMUNE-MEDIATED ADVERSE REACTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
SYSTEMIC IMMUNE ACTIVATION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.78%
5/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
BRONCHITIS
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CELLULITIS
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ENCEPHALITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
EPSTEIN-BARR VIRUS INFECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
FOURNIER'S GANGRENE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
GASTROENTERITIS CLOSTRIDIAL
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
GINGIVITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
INFECTED LYMPHOCELE
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
INFECTION
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
INFECTIOUS MONONUCLEOSIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
INFLUENZA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
MENINGITIS BACTERIAL
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
MENINGOENCEPHALITIS HERPETIC
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PELVIC ABSCESS
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PELVIC INFECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PERITONITIS
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PERITONSILLITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA
|
1.6%
10/642 • Number of events 10 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
7/644 • Number of events 7 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PULPITIS DENTAL
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.62%
4/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
SEPSIS
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.4%
9/644 • Number of events 9 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
SKIN INFECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
TONSILLITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.4%
9/642 • Number of events 9 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.78%
5/644 • Number of events 6 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
UROSEPSIS
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
VAGINAL ABSCESS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
VAGINAL CELLULITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
FRACTURED SACRUM
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL ANASTOMOTIC LEAK
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL INJURY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
INCISION SITE IMPAIRED HEALING
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.78%
5/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
PERIPROSTHETIC FRACTURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
PROCEDURAL INTESTINAL PERFORATION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
VAGINAL CUFF DEHISCENCE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
LIPASE INCREASED
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.1%
7/644 • Number of events 7 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.93%
6/642 • Number of events 9 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.6%
10/644 • Number of events 13 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.93%
6/642 • Number of events 6 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
FOOD REFUSAL
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.62%
4/642 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.62%
4/644 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAPLASTIC ASTROCYTOMA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL STROMAL TUMOUR
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
APHASIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.31%
2/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DEMENTIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
MYASTHENIA GRAVIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
SEIZURE
|
0.31%
2/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.62%
4/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
DEPRESSION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
IMMUNE-MEDIATED NEPHRITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
NEPHRITIS
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
NEPHROPATHY
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
UROGENITAL FISTULA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Reproductive system and breast disorders
VAGINAL FISTULA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
LOWER RESPIRATORY TRACT CONGESTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.78%
5/642 • Number of events 6 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.6%
10/642 • Number of events 10 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.93%
6/644 • Number of events 6 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
LICHEN PLANUS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.1%
7/642 • Number of events 7 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
AORTIC DISSECTION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.31%
2/642 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
EMBOLISM
|
0.47%
3/642 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.47%
3/644 • Number of events 3 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
EMBOLISM VENOUS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HAEMORRHAGE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPERTENSION
|
0.78%
5/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.62%
4/644 • Number of events 4 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPERTENSIVE URGENCY
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
LYMPHOCELE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
LYMPHORRHOEA
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
MYELOSUPPRESSION
|
0.47%
3/642 • Number of events 5 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Immune system disorders
SARCOIDOSIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.00%
0/644 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
STOMA PROLAPSE
|
0.16%
1/642 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.31%
2/644 • Number of events 2 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS CHRONIC
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.00%
0/642 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
0.16%
1/644 • Number of events 1 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
Other adverse events
| Measure |
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
n=642 participants at risk
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
Placebo With Paclitaxel, Carboplatin and Bevacizumab
n=644 participants at risk
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
44.2%
284/642 • Number of events 468 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
41.3%
266/644 • Number of events 440 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
10.7%
69/642 • Number of events 197 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
11.8%
76/644 • Number of events 243 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
30.4%
195/642 • Number of events 477 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
30.6%
197/644 • Number of events 507 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
21.3%
137/642 • Number of events 278 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
20.8%
134/644 • Number of events 275 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
7.9%
51/642 • Number of events 56 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.6%
23/644 • Number of events 26 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
18.4%
118/642 • Number of events 131 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.4%
54/644 • Number of events 57 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Eye disorders
VISION BLURRED
|
4.8%
31/642 • Number of events 34 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.0%
45/644 • Number of events 48 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
6.1%
39/642 • Number of events 51 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.6%
49/644 • Number of events 60 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
28.3%
182/642 • Number of events 253 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
26.9%
173/644 • Number of events 241 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.6%
49/642 • Number of events 56 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.2%
66/644 • Number of events 98 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
35.2%
226/642 • Number of events 297 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
37.3%
240/644 • Number of events 334 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
34.7%
223/642 • Number of events 336 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
30.9%
199/644 • Number of events 328 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.3%
34/642 • Number of events 39 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.8%
18/644 • Number of events 22 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.9%
44/642 • Number of events 54 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.2%
53/644 • Number of events 61 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
50.6%
325/642 • Number of events 565 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
52.3%
337/644 • Number of events 628 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
15.3%
98/642 • Number of events 138 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.4%
67/644 • Number of events 106 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
VOMITING
|
23.4%
150/642 • Number of events 209 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
24.2%
156/644 • Number of events 230 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
ASTHENIA
|
12.1%
78/642 • Number of events 102 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.3%
79/644 • Number of events 117 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
FATIGUE
|
37.5%
241/642 • Number of events 297 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
39.0%
251/644 • Number of events 339 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MALAISE
|
5.5%
35/642 • Number of events 59 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.1%
33/644 • Number of events 42 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
7.0%
45/642 • Number of events 49 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
4.0%
26/644 • Number of events 36 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
6.2%
40/642 • Number of events 44 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.2%
40/644 • Number of events 42 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PYREXIA
|
16.2%
104/642 • Number of events 124 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.4%
54/644 • Number of events 75 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
41/642 • Number of events 60 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.4%
41/644 • Number of events 59 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.8%
63/642 • Number of events 83 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.5%
55/644 • Number of events 71 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
17.0%
109/642 • Number of events 169 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
16.1%
104/644 • Number of events 140 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
12.1%
78/642 • Number of events 116 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.8%
50/644 • Number of events 71 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
14.2%
91/642 • Number of events 142 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.2%
59/644 • Number of events 100 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
13.9%
89/642 • Number of events 149 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.7%
56/644 • Number of events 93 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
6.2%
40/642 • Number of events 50 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.1%
33/644 • Number of events 48 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
6.5%
42/642 • Number of events 55 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
3.7%
24/644 • Number of events 44 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
27.6%
177/642 • Number of events 567 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
26.1%
168/644 • Number of events 610 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
21.3%
137/642 • Number of events 267 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
22.0%
142/644 • Number of events 329 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
WEIGHT DECREASED
|
13.1%
84/642 • Number of events 91 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
10.6%
68/644 • Number of events 72 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
WEIGHT INCREASED
|
7.8%
50/642 • Number of events 51 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.8%
44/644 • Number of events 46 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
22.3%
143/642 • Number of events 455 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
18.9%
122/644 • Number of events 535 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
18.5%
119/642 • Number of events 160 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
18.6%
120/644 • Number of events 154 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
7.2%
46/642 • Number of events 69 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
8.1%
52/644 • Number of events 85 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.2%
72/642 • Number of events 97 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.3%
60/644 • Number of events 94 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
14.3%
92/642 • Number of events 134 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.9%
83/644 • Number of events 112 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
7.5%
48/642 • Number of events 63 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.0%
45/644 • Number of events 61 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
44.5%
286/642 • Number of events 444 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
44.3%
285/644 • Number of events 451 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
13.7%
88/642 • Number of events 97 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
14.0%
90/644 • Number of events 115 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
7.0%
45/642 • Number of events 70 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.9%
51/644 • Number of events 92 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
7.0%
45/642 • Number of events 50 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.8%
44/644 • Number of events 57 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
22.4%
144/642 • Number of events 205 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
25.3%
163/644 • Number of events 239 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.3%
34/642 • Number of events 34 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.0%
32/644 • Number of events 35 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.6%
81/642 • Number of events 110 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
13.8%
89/644 • Number of events 121 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DIZZINESS
|
11.8%
76/642 • Number of events 93 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.4%
80/644 • Number of events 102 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
DYSGEUSIA
|
8.7%
56/642 • Number of events 66 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.8%
50/644 • Number of events 52 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HEADACHE
|
23.2%
149/642 • Number of events 220 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
27.8%
179/644 • Number of events 278 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
HYPOAESTHESIA
|
7.8%
50/642 • Number of events 63 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.2%
59/644 • Number of events 78 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
23.7%
152/642 • Number of events 175 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
25.8%
166/644 • Number of events 196 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
PARAESTHESIA
|
7.3%
47/642 • Number of events 57 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.2%
40/644 • Number of events 65 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
27.7%
178/642 • Number of events 201 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
25.3%
163/644 • Number of events 186 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
ANXIETY
|
5.9%
38/642 • Number of events 43 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.6%
49/644 • Number of events 58 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
DEPRESSION
|
5.5%
35/642 • Number of events 41 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.9%
38/644 • Number of events 41 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Psychiatric disorders
INSOMNIA
|
13.9%
89/642 • Number of events 100 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
15.1%
97/644 • Number of events 119 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Renal and urinary disorders
PROTEINURIA
|
21.3%
137/642 • Number of events 172 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
21.7%
140/644 • Number of events 178 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.9%
102/642 • Number of events 127 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
12.4%
80/644 • Number of events 101 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
6.9%
44/642 • Number of events 47 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.8%
44/644 • Number of events 50 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
13.6%
87/642 • Number of events 112 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
13.4%
86/644 • Number of events 110 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
21.2%
136/642 • Number of events 166 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
21.6%
139/644 • Number of events 178 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.0%
32/642 • Number of events 38 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.6%
36/644 • Number of events 40 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
7.3%
47/642 • Number of events 58 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
6.4%
41/644 • Number of events 50 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
60.1%
386/642 • Number of events 393 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
63.7%
410/644 • Number of events 415 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.5%
35/642 • Number of events 37 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.1%
33/644 • Number of events 39 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
13.6%
87/642 • Number of events 108 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
9.5%
61/644 • Number of events 74 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
23.7%
152/642 • Number of events 205 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
15.4%
99/644 • Number of events 119 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
7.0%
45/642 • Number of events 67 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
2.6%
17/644 • Number of events 19 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
5.1%
33/642 • Number of events 49 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
1.6%
10/644 • Number of events 12 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HOT FLUSH
|
5.5%
35/642 • Number of events 37 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
7.5%
48/644 • Number of events 57 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Vascular disorders
HYPERTENSION
|
35.0%
225/642 • Number of events 354 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
40.8%
263/644 • Number of events 392 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.4%
28/642 • Number of events 29 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.1%
33/644 • Number of events 39 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
|
General disorders
PAIN
|
5.1%
33/642 • Number of events 35 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
5.0%
32/644 • Number of events 39 • From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER