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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]