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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 (IMagyn050)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03038100
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : February 17, 2023
Last Update Posted : February 17, 2023
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Interventions Drug: Paclitaxel
Drug: Carboplatin
Drug: Atezolizumab
Drug: Bevacizumab
Drug: Atezolizumab Placebo
Enrollment 1301
Recruitment Details The study is considered "Completed" because all pre-planned study activities and analyses have been performed.
Pre-assignment Details  
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 650 651
Completed 0 0
Not Completed 650 651
Reason Not Completed
Death             289             272
Lost to Follow-up             9             10
Protocol Deviation             1             4
Withdrawal by Subject             45             51
Study Terminated By Sponsor             305             311
Physician Decision             1             3
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 650 651 1301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 650 participants 651 participants 1301 participants
59.3  (10.7) 58.9  (10.5) 59.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 650 participants 651 participants 1301 participants
Female
650
 100.0%
651
 100.0%
1301
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 650 participants 651 participants 1301 participants
Hispanic or Latino
38
   5.8%
39
   6.0%
77
   5.9%
Not Hispanic or Latino
598
  92.0%
589
  90.5%
1187
  91.2%
Unknown or Not Reported
14
   2.2%
23
   3.5%
37
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 650 participants 651 participants 1301 participants
American Indian or Alaska Native
6
   0.9%
5
   0.8%
11
   0.8%
Asian
155
  23.8%
150
  23.0%
305
  23.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.3%
2
   0.2%
Black or African American
13
   2.0%
8
   1.2%
21
   1.6%
White
461
  70.9%
464
  71.3%
925
  71.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
15
   2.3%
22
   3.4%
37
   2.8%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame From randomization until disease progression or death from any cause (up to approximately 55 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 650 651
Median (95% Confidence Interval)
Unit of Measure: Months
18.37
(17.22 to 19.75)
19.48
(18.14 to 20.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2785
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.79 to 1.07
Estimation Comments [Not Specified]
2.Primary Outcome
Title PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
Hide Description 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.
Time Frame From randomization until disease progression or death from any cause (up to approximately 55 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 393 391
Median (95% Confidence Interval)
Unit of Measure: Months
18.50
(16.62 to 21.36)
20.83
(19.06 to 24.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0376
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.65 to 0.99
Estimation Comments [Not Specified]
3.Primary Outcome
Title Overall Survival - ITT Population
Hide Description Overall Survival (OS) is defined as the time from randomization to death from any cause.
Time Frame From randomization up to death from any cause (up to approximately 59 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 650 651
Median (95% Confidence Interval)
Unit of Measure: Months
46.59
(45.31 to 49.74)
50.53 [1] 
(46.26 to NA)
[1]
The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3432
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.78 to 1.09
Estimation Comments [Not Specified]
4.Primary Outcome
Title Overall Survival - PD-L1-Positive Subpopulation
Hide Description Overall Survival (OS) is defined as the time from randomization to death from any cause.
Time Frame From randomization up to death from any cause (up to approximately 59 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 393 391
Median (95% Confidence Interval)
Unit of Measure: Months
49.15 [1] 
(45.54 to NA)
NA [2] 
(NA to NA)
[1]
The upper limit of 95% CI was not estimable by Brookmeyer and Crowley method due to insufficient observed events.
[2]
67.3% of the participants were censored and the median was not reached.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1316
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.66 to 1.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
Hide Description 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.
Time Frame From randomization until disease progression or death from any cause (up to approximately 55 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 650 651
Measure Type: Number
Unit of Measure: Percentage of participants
88.7 92.8
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame From randomization until disease progression or death from any cause (up to approximately 55 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 393 391
Measure Type: Number
Unit of Measure: Percentage of participants
89.9 92.3
7.Secondary Outcome
Title Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 650 651
Median (95% Confidence Interval)
Unit of Measure: Months
14.06
(13.01 to 16.62)
16.59
(14.52 to 19.09)
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 142 156
Median (95% Confidence Interval)
Unit of Measure: Months
13.44
(12.71 to 19.29)
17.71
(15.01 to 19.61)
9.Secondary Outcome
Title Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 157 152
Measure Type: Number
Unit of Measure: Percentage of participants
Abdominal Pain, Presurgical/Surgery Number Analyzed 142 participants 136 participants
54.2 50.7
Abdominal Pain, Cycle 4 Day 1 Number Analyzed 140 participants 133 participants
36.4 32.3
Abdominal Pain, Cycle 6 Day 1 Number Analyzed 131 participants 133 participants
55.0 48.1
Abdominal Pain, Cycle 8 Day 1 Number Analyzed 129 participants 122 participants
64.3 54.1
Abdominal Pain, Cycle 12 Day 1 Number Analyzed 111 participants 101 participants
63.1 57.4
Abdominal Pain, Cycle 16 Day 1 Number Analyzed 96 participants 88 participants
63.5 58.0
Abdominal Pain, Cycle 20 Day 1 Number Analyzed 83 participants 62 participants
68.7 48.4
Abdominal Pain, Completion of Treatment/Early Termination Visit Number Analyzed 143 participants 130 participants
51.0 51.5
Abdominal Pain, Post-Treatment Follow Up 3 Months Number Analyzed 96 participants 96 participants
58.3 51.0
Abdominal Pain, Post-Treatment Follow Up 6 Months Number Analyzed 75 participants 74 participants
61.3 51.4
Abdominal Pain, Post-Treatment Follow Up 9 Months Number Analyzed 43 participants 38 participants
60.5 50.0
Abdominal Pain, Post-Treatment Follow Up 12 Months Number Analyzed 17 participants 24 participants
70.6 58.3
Abdominal Pain, Post-Treatment Follow Up 18 Months Number Analyzed 6 participants 4 participants
100 50
Abdominal Pain, Post-Treatment Follow Up 24 Months Number Analyzed 1 participants 2 participants
100 100
Bloating, Presurgical/Surgery Number Analyzed 142 participants 137 participants
62.7 54.0
Bloating, Cycle 4 Day 1 Number Analyzed 140 participants 132 participants
65.0 59.8
Bloating, Cycle 6 Day 1 Number Analyzed 131 participants 133 participants
71.0 66.9
Bloating, Cycle 8 Day 1 Number Analyzed 128 participants 123 participants
71.9 63.4
Bloating, Cycle 12 Day 1 Number Analyzed 111 participants 101 participants
68.5 63.4
Bloating, Cycle 16 Day 1 Number Analyzed 96 participants 88 participants
66.7 64.8
Bloating, Cycle 20 Day 1 Number Analyzed 83 participants 62 participants
66.3 56.5
Bloating, Completion of Treatment/ Early Termination Visit Number Analyzed 145 participants 130 participants
62.1 58.5
Bloating, Post-Treatment Follow Up 3 Months Number Analyzed 96 participants 96 participants
57.3 53.1
Bloating, Post-Treatment Follow Up 6 Months Number Analyzed 76 participants 74 participants
59.2 62.2
Bloating, Post-Treatment Follow Up 9 Months Number Analyzed 43 participants 38 participants
67.4 63.2
Bloating, Post-Treatment Follow Up 12 Months Number Analyzed 17 participants 24 participants
47.1 62.5
Bloating, Post-Treatment Follow Up 18 Months Number Analyzed 6 participants 4 participants
66.7 50.0
Bloating, Post-Treatment Follow Up 24 Months Number Analyzed 1 participants 2 participants
0 100
10.Secondary Outcome
Title Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 157 152
Measure Type: Number
Unit of Measure: Percentage of participants
Physical Functioning, Presurgical/Surgery Number Analyzed 142 participants 137 participants
35.9 33.6
Physical Functioning, Cycle 4 Day 1 Number Analyzed 141 participants 133 participants
28.4 18.0
Physical Functioning, Cycle 6 Day 1 Number Analyzed 132 participants 133 participants
35.6 25.6
Physical Functioning, Cycle 8 Day 1 Number Analyzed 129 participants 123 participants
37.2 36.6
Physical Functioning, Cycle 12 Day 1 Number Analyzed 111 participants 102 participants
45.9 43.1
Physical Functioning, Cycle 16 Day 1 Number Analyzed 96 participants 88 participants
42.7 42.0
Physical Functioning, Cycle 20 Day 1 Number Analyzed 83 participants 63 participants
41.0 31.7
Physical Functioning, Completion of Treatment/Early Termination Visit Number Analyzed 144 participants 131 participants
38.9 34.4
Physical Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 97 participants 97 participants
37.1 39.2
Physical Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 76 participants 74 participants
40.8 39.2
Physical Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 43 participants 38 participants
32.6 50.0
Physical Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 17 participants 24 participants
23.5 37.5
Physical Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 6 participants 4 participants
33.3 50.0
Physical Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 1 participants 2 participants
100 50
Role Functioning, Presurgical/Surgery Number Analyzed 142 participants 137 participants
48.6 40.9
Role Functioning, Cycle 4 Day 1 Number Analyzed 141 participants 133 participants
38.3 22.6
Role Functioning, Cycle 6 Day 1 Number Analyzed 133 participants 134 participants
45.9 33.6
Role Functioning, Cycle 8 Day 1 Number Analyzed 129 participants 123 participants
50.4 39.8
Role Functioning, Cycle 12 Day 1 Number Analyzed 111 participants 102 participants
55.9 47.1
Role Functioning, Cycle 16 Day 1 Number Analyzed 96 participants 88 participants
53.1 46.6
Role Functioning, Cycle 20 Day 1 Number Analyzed 83 participants 63 participants
56.6 52.4
Role Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 145 participants 131 participants
46.9 39.7
Role Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 97 participants 97 participants
49.5 40.2
Role Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 76 participants 74 participants
51.3 48.6
Role Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 43 participants 38 participants
53.5 52.6
Role Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 17 participants 24 participants
23.5 54.2
Role Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 6 participants 4 participants
50.0 50.0
Role Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 1 participants 2 participants
0 50
Social Functioning, Presurgical/Surgery Number Analyzed 142 participants 137 participants
32.4 33.6
Social Functioning, Cycle 4 Day 1 Number Analyzed 141 participants 133 participants
31.2 25.6
Social Functioning, Cycle 6 Day 1 Number Analyzed 133 participants 132 participants
36.8 33.3
Social Functioning, Cycle 8 Day 1 Number Analyzed 129 participants 122 participants
40.3 39.3
Social Functioning, Cycle 12 Day 1 Number Analyzed 111 participants 101 participants
39.6 44.6
Social Functioning, Cycle 16 Day 1 Number Analyzed 95 participants 88 participants
40.0 44.3
Social Functioning, Cycle 20 Day 1 Number Analyzed 83 participants 62 participants
45.8 43.5
Social Functioning, Completion of Treatment/Early Termination Number Analyzed 144 participants 130 participants
40.3 41.5
Social Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 96 participants 96 participants
42.7 44.8
Social Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 76 participants 74 participants
46.1 35.1
Social Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 43 participants 38 participants
46.5 47.4
Social Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 17 participants 24 participants
29.4 54.2
Social Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 6 participants 4 participants
66.7 75.0
Social Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 1 participants 2 participants
0 50
Emotional Functioning, Presurgical/Surgery Number Analyzed 142 participants 137 participants
31.7 30.7
Emotional Functioning, Cycle 4 Day 1 Number Analyzed 141 participants 132 participants
31.2 35.6
Emotional Functioning, Cycle 6 Day 1 Number Analyzed 133 participants 131 participants
42.1 38.2
Emotional Functioning, Cycle 8 Day 1 Number Analyzed 129 participants 123 participants
39.5 44.7
Emotional Functioning, Cycle 12 Day 1 Number Analyzed 111 participants 101 participants
41.4 41.6
Emotional Functioning, Cycle 16 Day 1 Number Analyzed 96 participants 88 participants
44.8 42.0
Emotional Functioning, Cycle 20 Day 1 Number Analyzed 83 participants 62 participants
44.6 32.3
Emotional Functioning, Completion of Treatment/Early Termination Visit Number Analyzed 145 participants 130 participants
33.8 33.8
Emotional Functioning, Post-Treatment Follow Up 3 months Number Analyzed 96 participants 96 participants
35.4 33.3
Emotional Functioning, Post-Treatment Follow Up 6 months Number Analyzed 76 participants 74 participants
30.3 33.8
Emotional Functioning, Post-Treatment Follow Up 9 months Number Analyzed 43 participants 38 participants
39.5 34.2
Emotional Functioning, Post-Treatment Follow Up 12 months Number Analyzed 17 participants 24 participants
29.4 29.2
Emotional Functioning, Post-Treatment Follow Up 18 months Number Analyzed 6 participants 4 participants
16.7 50.0
Emotional Functioning, Post-Treatment Follow Up 24 months Number Analyzed 1 participants 2 participants
0 50
GHS/HRQoL, PresurgicalSurgery Number Analyzed 142 participants 137 participants
44.4 46.7
GHS/HRQoL, Cycle 4 Day 1 Number Analyzed 141 participants 132 participants
43.3 37.1
GHS/HRQoL, Cycle 6 Day 1 Number Analyzed 133 participants 132 participants
51.1 47.7
GHS/HRQoL, Cycle 8 Day 1 Number Analyzed 129 participants 122 participants
55.0 59.0
GHS/HRQoL, Cycle 12 Day 1 Number Analyzed 111 participants 101 participants
60.4 61.4
GHS/HRQoL, Cycle 16 Day 1 Number Analyzed 96 participants 88 participants
53.1 58.0
GHS/HRQoL, Cycle 20 Day 1 Number Analyzed 83 participants 62 participants
59.0 61.3
GHS/HRQoL, Completion of Treatment/ Early Termination Visit Number Analyzed 145 participants 130 participants
46.9 53.1
GHS/HRQoL, Post-Treatment Follow Up 3 Months Number Analyzed 95 participants 96 participants
53.7 53.1
GHS/HRQoL, Post-Treatment Follow Up 6 Months Number Analyzed 76 participants 74 participants
48.7 41.9
GHS/HRQoL, Post-Treatment Follow Up 9 Months Number Analyzed 43 participants 38 participants
39.5 50.0
GHS/HRQoL, Post-Treatment Follow Up 12 Months Number Analyzed 17 participants 24 participants
17.6 41.7
GHS/HRQoL, Post-Treatment Follow Up 18 Months Number Analyzed 6 participants 4 participants
16.7 50.0
GHS/HRQoL, Post-Treatment Follow Up 24 Months Number Analyzed 1 participants 2 participants
0 50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Presurgical/Surgery
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9096
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.58 to 1.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 4 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4662
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.73 to 2.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 6 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5237
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.51 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3826
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.76 to 2.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9893
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.56 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6892
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.49 to 1.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1324
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.30 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Completion of Treatment/Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9176
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.62 to 1.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7861
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.50 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4539
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.65 to 2.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4849
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.27 to 1.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7470
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.19 to 3.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0896
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-44.86 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-94.30 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Presurgical/Surgery
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7347
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.56 to 1.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Cycle 4 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0479
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.32 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Cycle 6 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0712
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.36 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8168
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.56 to 1.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6417
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.50 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8821
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.53 to 1.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2158
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.32 to 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Completion of Treatment/Early Termination Visit
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4762
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.51 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7585
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.61 to 1.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9985
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.52 to 1.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1067
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.07
Confidence Interval (2-Sided) 95%
0.85 to 5.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6171
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
0.36 to 5.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8084
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
0.08 to 23.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical Functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value -50.00
Confidence Interval (2-Sided) 95%
-100.00 to 94.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Presurgical/Surgery
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6802
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.69 to 1.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 4 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3470
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.48 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 6 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5564
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.53 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.72 to 1.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9778
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.57 to 1.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.65 to 2.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9900
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.50 to 2.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Completion of Treatment/Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2634
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.81 to 2.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9640
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.56 to 1.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4117
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.40 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3505
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
0.63 to 3.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2439
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.28
Confidence Interval (2-Sided) 95%
0.55 to 9.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1573
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-44.86 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-94.30 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role Functioning, Presurgical/Surgery
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1820
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.45 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 4 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.28 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 6 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0361
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.36 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0848
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.39 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1224
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.37 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3127
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.41 to 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6065
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.42 to 1.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.45 to 1.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1316
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.35 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7678
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.46 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7331
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.34 to 2.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1235
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.83
Confidence Interval (2-Sided) 95%
0.73 to 10.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-84.09 to 84.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-94.30 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Presurgical/Surgery
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7869
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.65 to 1.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 4 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2502
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.43 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 6 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5066
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.50 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8124
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.56 to 1.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4656
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.70 to 2.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6725
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.62 to 2.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5780
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.41 to 1.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Completion of Treatment/Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7611
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.66 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7588
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.62 to 1.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1428
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.30 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9802
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.41 to 2.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1967
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.34
Confidence Interval (2-Sided) 95%
0.63 to 8.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4795
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Respnders
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
-69.28 to 85.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-94.30 to 100.00
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 473 473
Measure Type: Number
Unit of Measure: Percentage of participants
Physical Functioning, Cycle 3 Day 1 Number Analyzed 456 participants 444 participants
22.6 19.8
Physical Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 423 participants
23.7 21.3
Physical Functioning, Cycle 8 Day 1 Number Analyzed 414 participants 403 participants
28.7 27.0
Physical Functioning, Cycle 12 Day 1 Number Analyzed 378 participants 358 participants
35.4 32.4
Physical Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
32.1 34.3
Physical Functioning, Cycle 20 Day 1 Number Analyzed 253 participants 234 participants
34.8 32.5
Physical Functioning, Completion of Treatment/Early Termination Visit Number Analyzed 370 participants 366 participants
32.4 30.3
Physical Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 235 participants 236 participants
35.7 28.4
Physical Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 147 participants 164 participants
32.7 31.1
Physical Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
34.5 27.6
Physical Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
37.8 24.1
Physical Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
42.9 18.8
Physical Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 16.7
Role Functioning, Cycle 3 Day 1 Number Analyzed 455 participants 443 participants
42.6 40.9
Role Functioning, Cycle 5 Day 1 Number Analyzed 438 participants 422 participants
42.9 38.9
Role Functioning, Cycle 8 Day 1 Number Analyzed 413 participants 401 participants
47.5 45.9
Role Functioning, Cycle 12 Day 1 Number Analyzed 377 participants 358 participants
50.1 50.6
Role Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 311 participants
52.0 50.8
Role Functioning, Cycle 20 Day 1 Number Analyzed 253 participants 233 participants
53.8 51.5
Role Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 370 participants 367 participants
48.4 46.6
Role Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 235 participants 236 participants
54.0 45.3
Role Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 147 participants 164 participants
55.1 43.9
Role Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
57.1 38.8
Role Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
60 27.6
Role Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
50 43.8
Role Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
50 16.7
Social Functioning, Cycle 3 Day 1 Number Analyzed 455 participants 442 participants
30.1 31.4
Social Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
32.6 32.0
Social Functioning, Cycle 8 Day 1 Number Analyzed 413 participants 403 participants
37.8 38.7
Social Functioning, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
42.6 41.2
Social Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
43.5 48.7
Social Functioning, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
45.6 50.0
Social Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 367 participants 367 participants
40.6 40.1
Social Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
42.7 41.1
Social Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
43.2 34.1
Social Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
50.0 36.7
Social Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
62.2 36.2
Social Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
57.1 43.8
Social Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
100 50
Emotional Functioning, Cycle 3 Day 1 Number Analyzed 454 participants 443 participants
29.7 28.4
Emotional Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
30.3 30.3
Emotional Functioning, Cycle 8 Day 1 Number Analyzed 412 participants 403 participants
32.3 33.0
Emotional Functioning, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
34.6 36.1
Emotional Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
31.8 35.9
Emotional Functioning, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
35.3 36.8
Emotional Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 368 participants 367 participants
27.7 28.6
Emotional Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
29.1 27.5
Emotional Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
30.4 37.8
Emotional Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
38.1 33.7
Emotional Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
44.4 34.5
Emotional Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
42.9 31.3
Emotional Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
50.0 16.7
GHS/OoL, Cycle 3 Day 1 Number Analyzed 455 participants 443 participants
32.3 34.5
GHS/OoL, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
33.0 31.0
GHS/OoL, Cycle 8 Day 1 Number Analyzed 413 participants 403 participants
39.5 38.7
GHS/OoL, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
41.5 43.4
GHS/OoL, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
42.9 42.9
GHS/OoL, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
42.5 46.2
GHS/OoL, Completion of Treatment/ Early Termination Visit Number Analyzed 368 participants 367 participants
38.0 34.9
GHS/OoL, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
40.6 38.6
GHS/OoL, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
39.2 34.1
GHS/OoL, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
39.3 35.7
GHS/OoL, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
40.0 32.8
GHS/OoL, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
42.9 18.8
GHS/OoL, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
100 33.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6651
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.70 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9927
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.75 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8209
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.77 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6507
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.79 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2596
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.87 to 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6532
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.75 to 1.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Completion Of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7592
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.76 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7424
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.62 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1912
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.85 to 2.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5526
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.45 to 1.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3609
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.32 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7527
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.20 to 3.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value -33.33
Confidence Interval (2-Sided) 95%
-100.00 to 75.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3177
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.62 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4184
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.63 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5710
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.67 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3973
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.65 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5163
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.80 to 1.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6897
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.64 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Completion Of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5735
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.67 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1414
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.50 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8655
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.59 to 1.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.38 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2325
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.26 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1717
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.06 to 1.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analsyis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-46.49 to 79.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4745
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.84 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5499
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.69 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8436
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.73 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5798
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.81 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9094
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.74 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.81 to 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4024
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.65 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8796
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.67 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4350
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.53 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6225
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.47 to 1.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5775
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.36 to 1.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2343
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.07 to 1.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0833
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value -66.67
Confidence Interval (2-Sided) 95%
-100.00 to 4.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Superiority
Statistical Test of Hypothesis P-Value 0.6012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.71 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2291
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.65 to 1.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6574
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.71 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9217
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.76 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7693
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.70 to 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6470
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.64 to 1.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Completion Of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6391
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.70 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0892
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.51 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0550
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.41 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0168
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.27 to 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.13 to 0.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7817
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.17 to 3.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -33.33
Confidence Interval (2-Sided) 95%
-100.00 to 75.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6646
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.80 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8677
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.73 to 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7670
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.79 to 1.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7487
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.71 to 1.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1882
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.90 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3015
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.84 to 1.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9059
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.73 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7125
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.65 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0947
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.43 to 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0686
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.32 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0175
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.17 to 0.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3376
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.09 to 2.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5637
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value -50.00
Confidence Interval (2-Sided) 95%
-100.00 to 23.34
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 473 473
Measure Type: Number
Unit of Measure: Percentage of participants
Physical Functioning, Cycle 3 Day 1 Number Analyzed 456 participants 444 participants
53.1 56.1
Physical Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 423 participants
49.0 50.1
Physical Functioning, Cycle 8 Day 1 Number Analyzed 414 participants 403 participants
47.8 49.4
Physical Functioning, Cycle 12 Day 1 Number Analyzed 378 participants 358 participants
47.1 51.1
Physical Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
50.5 48.7
Physical Functioning, Cycle 20 Day 1 Number Analyzed 253 participants 234 participants
46.6 50.9
Physical Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 370 participants 366 participants
46.8 44.5
Physical Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 235 participants 236 participants
41.3 47.9
Physical Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 147 participants 164 participants
42.2 43.9
Physical Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
46.4 46.9
Physical Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
44.4 50.0
Physical Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
35.7 56.3
Physical Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
100 33.3
Role Functioning, Cycle 3 Day 1 Number Analyzed 455 participants 443 participants
35.8 30.9
Role Functioning, Cycle 5 Day 1 Number Analyzed 438 participants 422 participants
30.1 33.6
Role Functioning, Cycle 8 Day 1 Number Analyzed 413 participants 401 participants
31.2 30.9
Role Functioning, Cycle 12 Day 1 Number Analyzed 377 participants 358 participants
32.9 32.1
Role Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 311 participants
27.6 33.4
Role Functioning, Cycle 20 Day 1 Number Analyzed 253 participants 233 participants
27.3 34.8
Role Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 370 participants 367 participants
28.6 28.6
Role Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 235 participants 236 participants
25.1 27.1
Role Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 147 participants 164 participants
24.5 29.9
Role Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
23.8 34.7
Role Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
33.3 34.5
Role Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
42.9 25.0
Role Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
50 66.7
Social Functioning, Cycle 3 Day 1 Number Analyzed 455 participants 442 participants
40.7 36.7
Social Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
37.6 36.7
Social Functioning, Cycle 8 Day 1 Number Analyzed 413 participants 403 participants
40.2 35.2
Social Functioning, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
38.3 39.2
Social Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
36.6 33.3
Social Functioning, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
34.1 33.8
Social Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 367 participants 367 participants
31.9 31.1
Social Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
30.3 32.6
Social Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
33.8 34.8
Social Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
27.4 30.6
Social Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
28.9 25.9
Social Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
28.6 18.8
Social Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 16.7
Emotional Functioning, Cycle 3 Day 1 Number Analyzed 454 participants 443 participants
57.5 57.3
Emotional Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
52.4 53.6
Emotional Functioning, Cycle 8 Day 1 Number Analyzed 412 participants 403 participants
53.2 54.6
Emotional Functioning, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
53.2 50.1
Emotional Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
55.0 51.3
Emotional Functioning, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
49.2 52.1
Emotional Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 368 participants 367 participants
53.0 51.8
Emotional Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
51.3 55.5
Emotional Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
48.6 47.6
Emotional Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
53.6 48.0
Emotional Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
46.7 43.1
Emotional Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
50.0 37.5
Emotional Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
50.0 16.7
GHS/OoL, Cycle 3 Day 1 Number Analyzed 455 participants 443 participants
43.3 42.2
GHS/OoL, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
42.6 44.8
GHS/OoL, Cycle 8 Day 1 Number Analyzed 413 participants 403 participants
39.0 42.9
GHS/OoL, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
40.7 42.9
GHS/OoL, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
38.4 43.3
GHS/OoL, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
36.9 42.3
GHS/OoL, Completion of Treatment/ Early Termination Visit Number Analyzed 368 participants 367 participants
37.2 40.3
GHS/OoL, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
38.9 38.6
GHS/OoL, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
39.9 42.1
GHS/OoL, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
39.3 38.8
GHS/OoL, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
42.2 32.8
GHS/OoL, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
35.7 37.5
GHS/OoL, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 16.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9770
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.76 to 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7317
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.80 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6937
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.80 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3916
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.66 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3363
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.63 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6761
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.75 to 1.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6997
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.71 to 1.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3592
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.82 to 1.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8798
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.62 to 1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3857
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.43 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6854
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.39 to 1.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4533
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.11 to 2.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional Functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value -33.33
Confidence Interval (2-Sided) 95%
-100.00 to 75.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3658
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.87 to 1.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7619
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.80 to 1.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6580
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.81 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2726
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.88 to 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6973
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.69 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4470
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.80 to 1.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5150
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.68 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2103
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.88 to 1.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7969
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.68 to 1.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8300
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.60 to 1.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6987
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.53 to 2.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1441
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.32
Confidence Interval (2-Sided) 95%
0.62 to 17.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion of Responders
Estimated Value -66.67
Confidence Interval (2-Sided) 95%
-100.00 to 4.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7591
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.74 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5403
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.83 to 1.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2654
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.89 to 1.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5138
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.82 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2138
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.89 to 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2114
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.88 to 1.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3938
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.85 to 1.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7793
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.65 to 1.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7370
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.69 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9658
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.55 to 1.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3015
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.29 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7534
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.15 to 3.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/ QoL, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5637
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-46.49 to 79.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1177
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.61 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2730
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.88 to 1.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9306
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.73 to 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8631
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.72 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0977
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.95 to 1.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0726
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
0.97 to 2.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9974
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.73 to 1.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7069
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.72 to 1.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3068
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.78 to 2.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1375
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
0.85 to 3.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9540
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.46 to 2.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4283
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.10 to 2.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-95.56 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2153
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.64 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7878
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.73 to 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1544
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.61 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.77 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4295
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.63 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9540
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.68 to 1.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7494
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.69 to 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6412
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.74 to 1.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8652
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.65 to 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6912
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.60 to 2.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5834
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.33 to 1.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9578
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.05 to 16.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social Functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5637
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-46.49 to 79.82
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 473 473
Measure Type: Number
Unit of Measure: Percentage of participants
Physical Functioning, Cycle 3 Day 1 Number Analyzed 456 participants 444 participants
24.1 24.1
Physical Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 423 participants
27.1 28.6
Physical Functioning, Cycle 8 Day 1 Number Analyzed 414 participants 403 participants
23.4 23.6
Physical Functioning, Cycle 12 Day 1 Number Analyzed 378 participants 358 participants
17.2 16.5
Physical Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
17.1 17.0
Physical Functioning, Cycle 20 Day 1 Number Analyzed 253 participants 234 participants
18.2 16.7
Physical Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 370 participants 366 participants
20.5 25.1
Physical Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 235 participants 236 participants
22.6 23.7
Physical Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 147 participants 164 participants
24.5 25.0
Physical Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
19.0 25.5
Physical Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
17.8 25.9
Physical Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
21.4 25.0
Physical Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 50
Role Functioning, Cycle 3 Day 1 Number Analyzed 455 participants 443 participants
21.3 27.8
Role Functioning, Cycle 5 Day 1 Number Analyzed 438 participants 422 participants
26.7 27.0
Role Functioning, Cycle 8 Day 1 Number Analyzed 413 participants 401 participants
21.1 22.7
Role Functioning, Cycle 12 Day 1 Number Analyzed 377 participants 358 participants
16.7 16.8
Role Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 311 participants
20.1 15.8
Role Functioning, Cycle 20 Day 1 Number Analyzed 253 participants 233 participants
18.6 13.3
Role Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 370 participants 367 participants
23.0 24.3
Role Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 235 participants 236 participants
20.9 27.1
Role Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 147 participants 164 participants
20.4 25.6
Role Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
19.0 26.5
Role Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
6.7 37.9
Role Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
7.1 31.3
Role Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 16.7
Social Functioning, Cycle 3 Day 1 Number Analyzed 455 participants 442 participants
29.0 31.2
Social Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
29.6 30.6
Social Functioning, Cycle 8 Day 1 Number Analyzed 413 participants 403 participants
21.8 25.8
Social Functioning, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
18.9 19.0
Social Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
19.5 17.6
Social Functioning, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
20.2 16.2
Social Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 367 participants 367 participants
27.2 28.1
Social Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
26.5 25.4
Social Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
23.0 30.5
Social Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
22.6 32.7
Social Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
8.9 37.9
Social Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
14.3 37.5
Social Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 33.3
Emotional Functioning, Cycle 3 Day 1 Number Analyzed 454 participants 443 participants
12.8 14.0
Emotional Functioning, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
17.3 15.9
Emotional Functioning, Cycle 8 Day 1 Number Analyzed 412 participants 403 participants
14.6 12.4
Emotional Functioning, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
12.2 13.4
Emotional Functioning, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
13.2 12.5
Emotional Functioning, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
15.5 11.1
Emotional Functioning, Completion of Treatment/ Early Termination Visit Number Analyzed 368 participants 367 participants
19.3 19.3
Emotional Functioning, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
19.7 16.9
Emotional Functioning, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
20.9 14.6
Emotional Functioning, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
8.3 18.4
Emotional Functioning, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
8.9 22.4
Emotional Functioning, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
7.1 31.3
Emotional Functioning, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 66.7
GHS/OoL Function, Cycle 3 Day 1 Number Analyzed 455 participants 443 participants
24.2 22.8
GHS/OoL Function, Cycle 5 Day 1 Number Analyzed 439 participants 422 participants
24.1 23.7
GHS/OoL Function, Cycle 8 Day 1 Number Analyzed 413 participants 403 participants
21.3 18.1
GHS/OoL Function, Cycle 12 Day 1 Number Analyzed 376 participants 357 participants
17.6 13.2
GHS/OoL Function, Cycle 16 Day 1 Number Analyzed 333 participants 312 participants
18.3 13.5
GHS/OoL Function, Cycle 20 Day 1 Number Analyzed 252 participants 234 participants
20.2 11.1
GHS/OoL Function, Completion of Treatment/ Early Termination Visit Number Analyzed 368 participants 367 participants
24.5 24.3
GHS/OoL Function, Post-Treatment Follow Up 3 Months Number Analyzed 234 participants 236 participants
20.5 22.9
GHS/OoL Function, Post-Treatment Follow Up 6 Months Number Analyzed 148 participants 164 participants
20.9 23.8
GHS/OoL Function, Post-Treatment Follow Up 9 Months Number Analyzed 84 participants 98 participants
21.4 25.5
GHS/OoL Function, Post-Treatment Follow Up 12 Months Number Analyzed 45 participants 58 participants
17.8 34.5
GHS/OoL Function, Post-Treatment Follow Up 18 Months Number Analyzed 14 participants 16 participants
21.4 43.8
GHS/OoL Function, Post-Treatment Follow Up 24 Months Number Analyzed 2 participants 6 participants
0 50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6063
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.75 to 1.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5739
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.63 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3792
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.56 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.73 to 1.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7893
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.59 to 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2125
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.42 to 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9661
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.70 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4299
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.52 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1542
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.36 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0363
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.65
Confidence Interval (2-Sided) 95%
1.04 to 6.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0814
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.75
Confidence Interval (2-Sided) 95%
0.85 to 8.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1915
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.03
Confidence Interval (2-Sided) 95%
0.43 to 38.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Emotional functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 66.67
Confidence Interval (2-Sided) 95%
-4.39 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9818
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.73 to 1.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6263
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.80 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9407
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.73 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7700
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.64 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8458
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.63 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7028
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.57 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1391
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.92 to 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.69 to 1.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9751
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.60 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3811
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.68 to 2.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3950
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
0.58 to 3.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8993
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.16 to 5.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Physical functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-23.34 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5988
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.68 to 1.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8859
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.72 to 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2531
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified Analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.58 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0785
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.46 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0641
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.43 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.29 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8928
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.70 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6106
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.72 to 1.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.6159
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.67 to 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5372
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified Analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.62 to 2.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0845
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
0.89 to 5.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1344
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.67
Confidence Interval (2-Sided) 95%
0.62 to 21.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Global health status/QoL, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.3173
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-23.34 to 100.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0260
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.04 to 1.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9179
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.75 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.5820
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.79 to 1.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9772
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.67 to 1.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1300
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.49 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0990
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.40 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7133
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.76 to 1.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1384
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
0.90 to 2.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2895
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.78 to 2.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2221
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
0.77 to 3.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.37
Confidence Interval (2-Sided) 95%
2.08 to 26.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2171
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.72
Confidence Interval (2-Sided) 95%
0.40 to 34.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Role functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-46.49 to 79.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 3 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4647
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.84 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 5 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7676
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.78 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 8 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1983
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.89 to 1.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 12 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.9874
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.69 to 1.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 16 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4716
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.58 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Cycle 20 Day 1
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2041
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.46 to 1.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Completion of Treatment/ Early Termination Visit
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.7771
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.76 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 3 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.8542
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.64 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 6 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1230
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
0.90 to 2.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 9 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1089
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
0.88 to 3.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 12 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.82
Confidence Interval (2-Sided) 95%
1.85 to 18.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 18 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2950
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.51
Confidence Interval (2-Sided) 95%
0.43 to 14.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo With Paclitaxel, Carboplatin and Bevacizumab, Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Comments Social functioning, Post-Treatment Follow Up 24 Months
Type of Statistical Test Superiority
Comments Stratified Analysis
Method of Estimation Estimation Parameter Difference in Proportion of Responders
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-37.72 to 100.00
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event
Hide Description Percentage of participants with at least one adverse event.
Time Frame From randomization up to approximately 59 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).
Arm/Group Title Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 644 642
Measure Type: Number
Unit of Measure: Percentage
99.8 100
15.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Atezolizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 538
Mean (Standard Deviation)
Unit of Measure: µg/mL
Cycle 1 Day 1 Number Analyzed 538 participants
487  (163)
Cycle 3 Day 1 Number Analyzed 499 participants
614  (209)
16.Secondary Outcome
Title Minimum Serum Concentration (Cmin) of Atezolizumab
Hide Description [Not Specified]
Time Frame Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 532
Mean (Standard Deviation)
Unit of Measure: µg/mL
Cycle 2 Day 1 Number Analyzed 532 participants
88.9  (35.8)
Cycle 3 Day 1 Number Analyzed 519 participants
146  (93.0)
Cycle 4 Day 1 Number Analyzed 502 participants
149  (88.1)
Cycle 8 Day 1 Number Analyzed 339 participants
242  (96.3)
Cycle 16 Day 1 Number Analyzed 213 participants
286  (111)
17.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Hide Description [Not Specified]
Time Frame Baseline to approximately 55 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 569
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline evaluable participants Number Analyzed 563 participants
0.7
Post-baseline evaluable participants Number Analyzed 569 participants
22.7
Time Frame From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
Adverse Event Reporting Description All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious & other adverse events reported based on safety population, which included participants who received any amount of any study drug.
 
Arm/Group Title Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Placebo With Paclitaxel, Carboplatin and Bevacizumab
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Placebo With Paclitaxel, Carboplatin and Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   272/651 (41.78%)      289/650 (44.46%)    
Hide Serious Adverse Events
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Placebo With Paclitaxel, Carboplatin and Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   304/642 (47.35%)      215/644 (33.39%)    
Blood and lymphatic system disorders     
AGRANULOCYTOSIS  1  0/642 (0.00%)  0 2/644 (0.31%)  2
ANAEMIA  1  6/642 (0.93%)  7 10/644 (1.55%)  10
FEBRILE NEUTROPENIA  1  54/642 (8.41%)  59 24/644 (3.73%)  25
GRANULOCYTOSIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
IMMUNE THROMBOCYTOPENIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
LEUKOPENIA  1  3/642 (0.47%)  3 2/644 (0.31%)  2
NEUTROPENIA  1  5/642 (0.78%)  5 5/644 (0.78%)  5
PANCYTOPENIA  1  1/642 (0.16%)  1 2/644 (0.31%)  2
THROMBOCYTOPENIA  1  8/642 (1.25%)  11 10/644 (1.55%)  12
THROMBOTIC MICROANGIOPATHY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MYELOSUPPRESSION  1  3/642 (0.47%)  5 2/644 (0.31%)  2
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
ANGINA UNSTABLE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ARRHYTHMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ATRIAL FIBRILLATION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ATRIAL TACHYCARDIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ATRIAL THROMBOSIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ATRIOVENTRICULAR BLOCK  1  0/642 (0.00%)  0 1/644 (0.16%)  1
CARDIAC ARREST  1  2/642 (0.31%)  2 0/644 (0.00%)  0
CARDIAC FAILURE  1  1/642 (0.16%)  1 1/644 (0.16%)  1
CARDIAC FAILURE CONGESTIVE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
CARDIOMYOPATHY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
CARDIOVASCULAR DISORDER  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MYOCARDIAL INFARCTION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
MYOCARDIAL ISCHAEMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MYOCARDITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
PALPITATIONS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Ear and labyrinth disorders     
OTOLITHIASIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
VERTIGO  1  0/642 (0.00%)  0 3/644 (0.47%)  3
Endocrine disorders     
ADDISON'S DISEASE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ADRENAL INSUFFICIENCY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
AUTOIMMUNE THYROIDITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPERPARATHYROIDISM  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPOTHYROIDISM  1  2/642 (0.31%)  2 1/644 (0.16%)  1
SECONDARY ADRENOCORTICAL INSUFFICIENCY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Eye disorders     
OCULAR MYASTHENIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
OPTIC NEUROPATHY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
RETINAL VEIN OCCLUSION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ULCERATIVE KERATITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL ADHESIONS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ABDOMINAL DISTENSION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ABDOMINAL HERNIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ABDOMINAL PAIN  1  9/642 (1.40%)  9 2/644 (0.31%)  2
ABDOMINAL PAIN LOWER  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ABDOMINAL PAIN UPPER  1  0/642 (0.00%)  0 2/644 (0.31%)  2
ANAL FISTULA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ANAL HAEMORRHAGE  1  1/642 (0.16%)  2 0/644 (0.00%)  0
ASCITES  1  0/642 (0.00%)  0 1/644 (0.16%)  1
COLITIS  1  11/642 (1.71%)  12 6/644 (0.93%)  6
CONSTIPATION  1  4/642 (0.62%)  4 5/644 (0.78%)  5
DIARRHOEA  1  9/642 (1.40%)  11 11/644 (1.71%)  13
DIARRHOEA HAEMORRHAGIC  1  1/642 (0.16%)  1 1/644 (0.16%)  1
DIVERTICULAR PERFORATION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DIVERTICULUM  1  0/642 (0.00%)  0 1/644 (0.16%)  1
DUODENAL PERFORATION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
DYSPEPSIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DYSPHAGIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ENTERITIS  1  2/642 (0.31%)  2 0/644 (0.00%)  0
ENTEROCOLITIS  1  1/642 (0.16%)  1 4/644 (0.62%)  4
ENTEROCUTANEOUS FISTULA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GASTRIC STENOSIS  1  1/642 (0.16%)  4 0/644 (0.00%)  0
GASTRITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GASTROINTESTINAL HAEMORRHAGE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GASTROINTESTINAL PERFORATION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
GINGIVAL PAIN  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HAEMORRHOIDAL HAEMORRHAGE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ILEAL PERFORATION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ILEUS  1  12/642 (1.87%)  14 8/644 (1.24%)  10
ILEUS PARALYTIC  1  0/642 (0.00%)  0 1/644 (0.16%)  1
INCARCERATED INGUINAL HERNIA  1  0/642 (0.00%)  0 2/644 (0.31%)  2
INCARCERATED UMBILICAL HERNIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
INTESTINAL OBSTRUCTION  1  8/642 (1.25%)  8 7/644 (1.09%)  9
INTESTINAL PERFORATION  1  2/642 (0.31%)  2 3/644 (0.47%)  3
LARGE INTESTINAL HAEMORRHAGE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
LARGE INTESTINAL OBSTRUCTION  1  1/642 (0.16%)  1 2/644 (0.31%)  2
LARGE INTESTINE PERFORATION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
LOWER GASTROINTESTINAL HAEMORRHAGE  1  2/642 (0.31%)  2 1/644 (0.16%)  1
MECHANICAL ILEUS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
NAUSEA  1  5/642 (0.78%)  5 5/644 (0.78%)  5
OBSTRUCTION GASTRIC  1  1/642 (0.16%)  1 0/644 (0.00%)  0
OESOPHAGITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ORAL LICHEN PLANUS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PANCREATIC FISTULA  1  2/642 (0.31%)  2 0/644 (0.00%)  0
PANCREATITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PERITONEAL ADHESIONS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PNEUMATOSIS INTESTINALIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
RECTAL HAEMORRHAGE  1  3/642 (0.47%)  3 1/644 (0.16%)  1
SMALL INTESTINAL OBSTRUCTION  1  10/642 (1.56%)  11 6/644 (0.93%)  6
SMALL INTESTINAL PERFORATION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
SUBILEUS  1  0/642 (0.00%)  0 2/644 (0.31%)  2
THROMBOSIS MESENTERIC VESSEL  1  1/642 (0.16%)  1 0/644 (0.00%)  0
UMBILICAL HERNIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
VOMITING  1  4/642 (0.62%)  5 7/644 (1.09%)  8
General disorders     
ASTHENIA  1  2/642 (0.31%)  2 0/644 (0.00%)  0
CONDITION AGGRAVATED  1  0/642 (0.00%)  0 1/644 (0.16%)  1
DEATH  1  2/642 (0.31%)  2 0/644 (0.00%)  0
DEVICE RELATED THROMBOSIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
EARLY SATIETY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
FATIGUE  1  4/642 (0.62%)  4 2/644 (0.31%)  2
GENERAL PHYSICAL HEALTH DETERIORATION  1  3/642 (0.47%)  4 0/644 (0.00%)  0
MUCOSAL INFLAMMATION  1  1/642 (0.16%)  1 1/644 (0.16%)  1
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  0/642 (0.00%)  0 1/644 (0.16%)  1
NON-CARDIAC CHEST PAIN  1  2/642 (0.31%)  2 2/644 (0.31%)  2
PAIN  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PYREXIA  1  26/642 (4.05%)  31 8/644 (1.24%)  9
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Hepatobiliary disorders     
CHOLESTASIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DRUG-INDUCED LIVER INJURY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HEPATIC FUNCTION ABNORMAL  1  1/642 (0.16%)  1 1/644 (0.16%)  1
HEPATOTOXICITY  1  0/642 (0.00%)  0 2/644 (0.31%)  2
IMMUNE-MEDIATED HEPATITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
JAUNDICE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
JAUNDICE CHOLESTATIC  1  1/642 (0.16%)  1 0/644 (0.00%)  0
LIVER INJURY  1  4/642 (0.62%)  4 1/644 (0.16%)  1
HEPATIC FAILURE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Immune system disorders     
ANAPHYLACTIC REACTION  1  0/642 (0.00%)  0 2/644 (0.31%)  2
ANAPHYLACTIC SHOCK  1  1/642 (0.16%)  1 1/644 (0.16%)  1
CONTRAST MEDIA ALLERGY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
CYTOKINE RELEASE SYNDROME  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DRUG HYPERSENSITIVITY  1  1/642 (0.16%)  1 3/644 (0.47%)  3
HYPERSENSITIVITY  1  0/642 (0.00%)  0 1/644 (0.16%)  1
IMMUNE-MEDIATED ADVERSE REACTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
SYSTEMIC IMMUNE ACTIVATION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
SARCOIDOSIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
Infections and infestations     
ABDOMINAL ABSCESS  1  5/642 (0.78%)  5 3/644 (0.47%)  3
ABDOMINAL INFECTION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
APPENDICITIS  1  0/642 (0.00%)  0 2/644 (0.31%)  2
BACTERAEMIA  1  0/642 (0.00%)  0 2/644 (0.31%)  3
BRONCHITIS  1  2/642 (0.31%)  2 2/644 (0.31%)  2
BRONCHITIS VIRAL  1  0/642 (0.00%)  0 1/644 (0.16%)  1
CELLULITIS  1  3/642 (0.47%)  3 2/644 (0.31%)  2
CLOSTRIDIUM DIFFICILE COLITIS  1  2/642 (0.31%)  2 0/644 (0.00%)  0
CLOSTRIDIUM DIFFICILE INFECTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DEVICE RELATED INFECTION  1  1/642 (0.16%)  1 1/644 (0.16%)  1
ENCEPHALITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
EPSTEIN-BARR VIRUS INFECTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ESCHERICHIA BACTERAEMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
FOURNIER'S GANGRENE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GASTROENTERITIS CLOSTRIDIAL  1  1/642 (0.16%)  1 0/644 (0.00%)  0
GINGIVITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HERPES ZOSTER  1  0/642 (0.00%)  0 1/644 (0.16%)  1
INFECTED LYMPHOCELE  1  4/642 (0.62%)  4 1/644 (0.16%)  1
INFECTION  1  3/642 (0.47%)  3 1/644 (0.16%)  1
INFECTIOUS MONONUCLEOSIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
INFLUENZA  1  1/642 (0.16%)  1 1/644 (0.16%)  1
KIDNEY INFECTION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
LYMPHANGITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
MENINGITIS BACTERIAL  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MENINGOENCEPHALITIS HERPETIC  1  1/642 (0.16%)  1 0/644 (0.00%)  0
NASOPHARYNGITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
PELVIC ABSCESS  1  2/642 (0.31%)  2 1/644 (0.16%)  1
PELVIC INFECTION  1  1/642 (0.16%)  1 1/644 (0.16%)  1
PERITONITIS  1  4/642 (0.62%)  4 0/644 (0.00%)  0
PERITONSILLITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
PNEUMONIA  1  10/642 (1.56%)  10 7/644 (1.09%)  7
PNEUMONIA BACTERIAL  1  0/642 (0.00%)  0 1/644 (0.16%)  1
PNEUMONIA VIRAL  1  0/642 (0.00%)  0 1/644 (0.16%)  1
POSTOPERATIVE ABSCESS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
POSTOPERATIVE WOUND INFECTION  1  2/642 (0.31%)  2 0/644 (0.00%)  0
PULPITIS DENTAL  1  0/642 (0.00%)  0 1/644 (0.16%)  1
PYELONEPHRITIS  1  4/642 (0.62%)  5 3/644 (0.47%)  3
PYELONEPHRITIS ACUTE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
SEPSIS  1  3/642 (0.47%)  3 9/644 (1.40%)  9
SKIN INFECTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
STAPHYLOCOCCAL SEPSIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
TONSILLITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  4/642 (0.62%)  4 1/644 (0.16%)  1
URINARY TRACT INFECTION  1  9/642 (1.40%)  9 5/644 (0.78%)  6
UROSEPSIS  1  4/642 (0.62%)  4 2/644 (0.31%)  2
VAGINAL ABSCESS  1  1/642 (0.16%)  1 1/644 (0.16%)  1
VAGINAL CELLULITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
VASCULAR DEVICE INFECTION  1  1/642 (0.16%)  1 1/644 (0.16%)  1
WOUND INFECTION  1  0/642 (0.00%)  0 3/644 (0.47%)  3
BACTERIAL SEPSIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DIVERTICULITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GASTROENTERITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Injury, poisoning and procedural complications     
ANKLE FRACTURE  1  1/642 (0.16%)  1 1/644 (0.16%)  1
CONCUSSION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
FALL  1  2/642 (0.31%)  2 1/644 (0.16%)  1
FASCIAL RUPTURE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
FOOT FRACTURE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
FRACTURE  1  1/642 (0.16%)  1 1/644 (0.16%)  1
FRACTURED SACRUM  1  1/642 (0.16%)  1 0/644 (0.00%)  0
GASTROINTESTINAL ANASTOMOTIC LEAK  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GASTROINTESTINAL INJURY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HIP FRACTURE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
INCISION SITE IMPAIRED HEALING  1  0/642 (0.00%)  0 1/644 (0.16%)  1
INCISIONAL HERNIA  1  0/642 (0.00%)  0 2/644 (0.31%)  2
INFUSION RELATED REACTION  1  5/642 (0.78%)  5 2/644 (0.31%)  2
PERIPROSTHETIC FRACTURE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
POST PROCEDURAL HAEMORRHAGE  1  1/642 (0.16%)  1 1/644 (0.16%)  1
PROCEDURAL INTESTINAL PERFORATION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
SPINAL COMPRESSION FRACTURE  1  1/642 (0.16%)  1 1/644 (0.16%)  1
VAGINAL CUFF DEHISCENCE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
WOUND COMPLICATION  1  0/642 (0.00%)  0 2/644 (0.31%)  3
WOUND DEHISCENCE  1  2/642 (0.31%)  2 3/644 (0.47%)  5
STOMA PROLAPSE  1  1/642 (0.16%)  1 2/644 (0.31%)  2
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/642 (0.16%)  1 0/644 (0.00%)  0
BLOOD CREATININE INCREASED  1  1/642 (0.16%)  1 0/644 (0.00%)  0
BLOOD POTASSIUM DECREASED  1  1/642 (0.16%)  1 0/644 (0.00%)  0
C-REACTIVE PROTEIN INCREASED  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HEPATIC ENZYME INCREASED  1  0/642 (0.00%)  0 2/644 (0.31%)  2
INTERNATIONAL NORMALISED RATIO INCREASED  1  1/642 (0.16%)  1 1/644 (0.16%)  1
LIPASE INCREASED  1  1/642 (0.16%)  1 0/644 (0.00%)  0
LYMPHOCYTE COUNT DECREASED  1  0/642 (0.00%)  0 1/644 (0.16%)  1
NEUTROPHIL COUNT DECREASED  1  3/642 (0.47%)  3 7/644 (1.09%)  7
PLATELET COUNT DECREASED  1  6/642 (0.93%)  9 10/644 (1.55%)  13
WHITE BLOOD CELL COUNT DECREASED  1  3/642 (0.47%)  3 2/644 (0.31%)  3
Metabolism and nutrition disorders     
DECREASED APPETITE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DEHYDRATION  1  6/642 (0.93%)  6 0/644 (0.00%)  0
ELECTROLYTE IMBALANCE  1  2/642 (0.31%)  2 0/644 (0.00%)  0
FOOD REFUSAL  1  0/642 (0.00%)  0 1/644 (0.16%)  1
HYPERCALCAEMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPERGLYCAEMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPERMAGNESAEMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPOKALAEMIA  1  1/642 (0.16%)  1 3/644 (0.47%)  3
HYPOMAGNESAEMIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPONATRAEMIA  1  4/642 (0.62%)  4 4/644 (0.62%)  5
TYPE 1 DIABETES MELLITUS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/642 (0.16%)  1 2/644 (0.31%)  2
BACK PAIN  1  0/642 (0.00%)  0 1/644 (0.16%)  1
FLANK PAIN  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MYALGIA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
MYOPATHY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MYOSITIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PAIN IN EXTREMITY  1  0/642 (0.00%)  0 1/644 (0.16%)  1
SPINAL PAIN  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ANAPLASTIC ASTROCYTOMA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
GASTROINTESTINAL STROMAL TUMOUR  1  0/642 (0.00%)  0 1/644 (0.16%)  1
INVASIVE DUCTAL BREAST CARCINOMA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PAPILLARY THYROID CANCER  1  0/642 (0.00%)  0 1/644 (0.16%)  1
Nervous system disorders     
APHASIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ATAXIA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
CEREBELLAR INFARCTION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
CEREBRAL INFARCTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
CEREBROVASCULAR ACCIDENT  1  2/642 (0.31%)  3 3/644 (0.47%)  3
COGNITIVE DISORDER  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DEMENTIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DEPRESSED LEVEL OF CONSCIOUSNESS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
DIZZINESS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ENCEPHALOPATHY  1  2/642 (0.31%)  2 0/644 (0.00%)  0
EPILEPSY  1  0/642 (0.00%)  0 1/644 (0.16%)  1
HAEMORRHAGE INTRACRANIAL  1  2/642 (0.31%)  2 1/644 (0.16%)  1
HEADACHE  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ISCHAEMIC STROKE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
MYASTHENIA GRAVIS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
NEUROPATHY PERIPHERAL  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PERIPHERAL MOTOR NEUROPATHY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PRESYNCOPE  1  2/642 (0.31%)  2 0/644 (0.00%)  0
SEIZURE  1  2/642 (0.31%)  3 0/644 (0.00%)  0
SUBARACHNOID HAEMORRHAGE  1  1/642 (0.16%)  1 1/644 (0.16%)  1
SYNCOPE  1  2/642 (0.31%)  2 2/644 (0.31%)  2
TRANSIENT ISCHAEMIC ATTACK  1  4/642 (0.62%)  5 2/644 (0.31%)  2
Psychiatric disorders     
DELIRIUM  1  0/642 (0.00%)  0 1/644 (0.16%)  1
DEPRESSION  1  1/642 (0.16%)  1 2/644 (0.31%)  3
SUICIDAL IDEATION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  3/642 (0.47%)  3 2/644 (0.31%)  2
HAEMATURIA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
HYDRONEPHROSIS  1  1/642 (0.16%)  1 1/644 (0.16%)  1
IMMUNE-MEDIATED NEPHRITIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
NEPHRITIS  1  2/642 (0.31%)  2 0/644 (0.00%)  0
NEPHROPATHY  1  0/642 (0.00%)  0 1/644 (0.16%)  1
PROTEINURIA  1  3/642 (0.47%)  3 3/644 (0.47%)  3
RENAL FAILURE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
URINARY TRACT OBSTRUCTION  1  0/642 (0.00%)  0 2/644 (0.31%)  2
UROGENITAL FISTULA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
GLOMERULONEPHRITIS CHRONIC  1  0/642 (0.00%)  0 1/644 (0.16%)  1
Reproductive system and breast disorders     
FEMALE GENITAL TRACT FISTULA  1  2/642 (0.31%)  2 2/644 (0.31%)  2
VAGINAL FISTULA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
HEAVY MENSTRUAL BLEEDING  1  0/642 (0.00%)  0 1/644 (0.16%)  1
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/642 (0.16%)  1 1/644 (0.16%)  1
ASPIRATION  1  0/642 (0.00%)  0 1/644 (0.16%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DYSPNOEA  1  3/642 (0.47%)  3 2/644 (0.31%)  2
EPISTAXIS  1  0/642 (0.00%)  0 1/644 (0.16%)  1
HYPERVENTILATION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPOXIA  1  2/642 (0.31%)  2 0/644 (0.00%)  0
LOWER RESPIRATORY TRACT CONGESTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
PLEURAL EFFUSION  1  0/642 (0.00%)  0 2/644 (0.31%)  2
PNEUMONITIS  1  5/642 (0.78%)  6 2/644 (0.31%)  2
PULMONARY EMBOLISM  1  10/642 (1.56%)  10 6/644 (0.93%)  6
PULMONARY HAEMORRHAGE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Skin and subcutaneous tissue disorders     
DRUG ERUPTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ECZEMA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
ERYTHEMA MULTIFORME  1  1/642 (0.16%)  1 0/644 (0.00%)  0
LICHEN PLANUS  1  1/642 (0.16%)  1 0/644 (0.00%)  0
RASH  1  7/642 (1.09%)  7 0/644 (0.00%)  0
RASH MACULO-PAPULAR  1  3/642 (0.47%)  3 0/644 (0.00%)  0
SKIN ULCER  1  0/642 (0.00%)  0 1/644 (0.16%)  1
STEVENS-JOHNSON SYNDROME  1  2/642 (0.31%)  2 0/644 (0.00%)  0
TOXIC SKIN ERUPTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
URTICARIA  1  1/642 (0.16%)  1 0/644 (0.00%)  0
Vascular disorders     
AORTIC DISSECTION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
CIRCULATORY COLLAPSE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
DEEP VEIN THROMBOSIS  1  2/642 (0.31%)  2 2/644 (0.31%)  2
EMBOLISM  1  3/642 (0.47%)  3 3/644 (0.47%)  3
EMBOLISM VENOUS  1  0/642 (0.00%)  0 2/644 (0.31%)  2
HAEMORRHAGE  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPERTENSION  1  5/642 (0.78%)  5 4/644 (0.62%)  4
HYPERTENSIVE URGENCY  1  1/642 (0.16%)  1 0/644 (0.00%)  0
HYPOTENSION  1  1/642 (0.16%)  1 1/644 (0.16%)  1
LYMPHOCELE  1  1/642 (0.16%)  1 2/644 (0.31%)  2
LYMPHORRHOEA  1  0/642 (0.00%)  0 1/644 (0.16%)  1
ORTHOSTATIC HYPOTENSION  1  1/642 (0.16%)  1 0/644 (0.00%)  0
SHOCK HAEMORRHAGIC  1  1/642 (0.16%)  1 0/644 (0.00%)  0
1
Term from vocabulary, MedDRA version 25.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Placebo With Paclitaxel, Carboplatin and Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   637/642 (99.22%)      637/644 (98.91%)    
Blood and lymphatic system disorders     
ANAEMIA  1  284/642 (44.24%)  468 266/644 (41.30%)  440
LEUKOPENIA  1  69/642 (10.75%)  197 76/644 (11.80%)  243
NEUTROPENIA  1  195/642 (30.37%)  477 197/644 (30.59%)  507
THROMBOCYTOPENIA  1  137/642 (21.34%)  278 134/644 (20.81%)  275
Endocrine disorders     
HYPERTHYROIDISM  1  51/642 (7.94%)  56 23/644 (3.57%)  26
HYPOTHYROIDISM  1  118/642 (18.38%)  131 54/644 (8.39%)  57
Eye disorders     
VISION BLURRED  1  31/642 (4.83%)  34 45/644 (6.99%)  48
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  39/642 (6.07%)  51 49/644 (7.61%)  60
ABDOMINAL PAIN  1  182/642 (28.35%)  253 173/644 (26.86%)  241
ABDOMINAL PAIN UPPER  1  49/642 (7.63%)  56 66/644 (10.25%)  98
CONSTIPATION  1  226/642 (35.20%)  297 240/644 (37.27%)  334
DIARRHOEA  1  223/642 (34.74%)  336 199/644 (30.90%)  328
DRY MOUTH  1  34/642 (5.30%)  39 18/644 (2.80%)  22
DYSPEPSIA  1  44/642 (6.85%)  54 53/644 (8.23%)  61
NAUSEA  1  325/642 (50.62%)  565 337/644 (52.33%)  628
STOMATITIS  1  98/642 (15.26%)  138 67/644 (10.40%)  106
VOMITING  1  150/642 (23.36%)  209 156/644 (24.22%)  230
GASTROOESOPHAGEAL REFLUX DISEASE  1  28/642 (4.36%)  29 33/644 (5.12%)  39
General disorders     
ASTHENIA  1  78/642 (12.15%)  102 79/644 (12.27%)  117
FATIGUE  1  241/642 (37.54%)  297 251/644 (38.98%)  339
MALAISE  1  35/642 (5.45%)  59 33/644 (5.12%)  42
MUCOSAL INFLAMMATION  1  45/642 (7.01%)  49 26/644 (4.04%)  36
OEDEMA PERIPHERAL  1  40/642 (6.23%)  44 40/644 (6.21%)  42
PYREXIA  1  104/642 (16.20%)  124 54/644 (8.39%)  75
PAIN  1  33/642 (5.14%)  35 32/644 (4.97%)  39
Infections and infestations     
NASOPHARYNGITIS  1  41/642 (6.39%)  60 41/644 (6.37%)  59
UPPER RESPIRATORY TRACT INFECTION  1  63/642 (9.81%)  83 55/644 (8.54%)  71
URINARY TRACT INFECTION  1  109/642 (16.98%)  169 104/644 (16.15%)  140
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION  1  78/642 (12.15%)  116 50/644 (7.76%)  71
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  91/642 (14.17%)  142 59/644 (9.16%)  100
ASPARTATE AMINOTRANSFERASE INCREASED  1  89/642 (13.86%)  149 56/644 (8.70%)  93
BLOOD ALKALINE PHOSPHATASE INCREASED  1  40/642 (6.23%)  50 33/644 (5.12%)  48
LYMPHOCYTE COUNT DECREASED  1  42/642 (6.54%)  55 24/644 (3.73%)  44
NEUTROPHIL COUNT DECREASED  1  177/642 (27.57%)  567 168/644 (26.09%)  610
PLATELET COUNT DECREASED  1  137/642 (21.34%)  267 142/644 (22.05%)  329
WEIGHT DECREASED  1  84/642 (13.08%)  91 68/644 (10.56%)  72
WEIGHT INCREASED  1  50/642 (7.79%)  51 44/644 (6.83%)  46
WHITE BLOOD CELL COUNT DECREASED  1  143/642 (22.27%)  455 122/644 (18.94%)  535
Metabolism and nutrition disorders     
DECREASED APPETITE  1  119/642 (18.54%)  160 120/644 (18.63%)  154
HYPERGLYCAEMIA  1  46/642 (7.17%)  69 52/644 (8.07%)  85
HYPOKALAEMIA  1  72/642 (11.21%)  97 60/644 (9.32%)  94
HYPOMAGNESAEMIA  1  92/642 (14.33%)  134 83/644 (12.89%)  112
HYPONATRAEMIA  1  48/642 (7.48%)  63 45/644 (6.99%)  61
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  286/642 (44.55%)  444 285/644 (44.25%)  451
BACK PAIN  1  88/642 (13.71%)  97 90/644 (13.98%)  115
BONE PAIN  1  45/642 (7.01%)  70 51/644 (7.92%)  92
MUSCULAR WEAKNESS  1  45/642 (7.01%)  50 44/644 (6.83%)  57
MYALGIA  1  144/642 (22.43%)  205 163/644 (25.31%)  239
NECK PAIN  1  34/642 (5.30%)  34 32/644 (4.97%)  35
PAIN IN EXTREMITY  1  81/642 (12.62%)  110 89/644 (13.82%)  121
Nervous system disorders     
DIZZINESS  1  76/642 (11.84%)  93 80/644 (12.42%)  102
DYSGEUSIA  1  56/642 (8.72%)  66 50/644 (7.76%)  52
HEADACHE  1  149/642 (23.21%)  220 179/644 (27.80%)  278
HYPOAESTHESIA  1  50/642 (7.79%)  63 59/644 (9.16%)  78
NEUROPATHY PERIPHERAL  1  152/642 (23.68%)  175 166/644 (25.78%)  196
PARAESTHESIA  1  47/642 (7.32%)  57 40/644 (6.21%)  65
PERIPHERAL SENSORY NEUROPATHY  1  178/642 (27.73%)  201 163/644 (25.31%)  186
Psychiatric disorders     
ANXIETY  1  38/642 (5.92%)  43 49/644 (7.61%)  58
DEPRESSION  1  35/642 (5.45%)  41 38/644 (5.90%)  41
INSOMNIA  1  89/642 (13.86%)  100 97/644 (15.06%)  119
Renal and urinary disorders     
PROTEINURIA  1  137/642 (21.34%)  172 140/644 (21.74%)  178
Respiratory, thoracic and mediastinal disorders     
COUGH  1  102/642 (15.89%)  127 80/644 (12.42%)  101
DYSPHONIA  1  44/642 (6.85%)  47 44/644 (6.83%)  50
DYSPNOEA  1  87/642 (13.55%)  112 86/644 (13.35%)  110
EPISTAXIS  1  136/642 (21.18%)  166 139/644 (21.58%)  178
NASAL CONGESTION  1  32/642 (4.98%)  38 36/644 (5.59%)  40
OROPHARYNGEAL PAIN  1  47/642 (7.32%)  58 41/644 (6.37%)  50
Skin and subcutaneous tissue disorders     
ALOPECIA  1  386/642 (60.12%)  393 410/644 (63.66%)  415
DRY SKIN  1  35/642 (5.45%)  37 33/644 (5.12%)  39
PRURITUS  1  87/642 (13.55%)  108 61/644 (9.47%)  74
RASH  1  152/642 (23.68%)  205 99/644 (15.37%)  119
RASH MACULO-PAPULAR  1  45/642 (7.01%)  67 17/644 (2.64%)  19
URTICARIA  1  33/642 (5.14%)  49 10/644 (1.55%)  12
Vascular disorders     
HOT FLUSH  1  35/642 (5.45%)  37 48/644 (7.45%)  57
HYPERTENSION  1  225/642 (35.05%)  354 263/644 (40.84%)  392
1
Term from vocabulary, MedDRA version 25.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03038100    
Other Study ID Numbers: YO39523
2016-003472-52 ( EudraCT Number )
First Submitted: January 30, 2017
First Posted: January 31, 2017
Results First Submitted: January 9, 2023
Results First Posted: February 17, 2023
Last Update Posted: February 17, 2023