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    Clinical Trial Results:
    A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Summary
    EudraCT number
    		 2016-003472-52
    Trial protocol
    		 ES   SE   NO   CZ   DE   AT   PL   FI   GR   DK   FR   BE   IT  
    Global end of trial date
    12 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2023
    First version publication date
    26 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    YO39523
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03038100
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other Sponsor ID: IMagyn050
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was designed to evaluate the efficacy and safety of atezolizumab administered with paclitaxel+carboplatin+bevacizumab (Atezo+CP+Bev) compared with placebo+paclitaxel+carboplatin+bevacizumab (Placebo+CP+Bev) in participants with newly diagnosed, untreated ovarian, fallopian tube, and/or primary peritoneal cancer.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 50 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 28
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Brazil: 19
    Country: Number of subjects enrolled
    China: 135
    Country: Number of subjects enrolled
    Czechia: 18
    Country: Number of subjects enrolled
    Germany: 65
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Finland: 19
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Greece: 26
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Italy: 83
    Country: Number of subjects enrolled
    Japan: 110
    Country: Number of subjects enrolled
    Korea, Republic of: 38
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Russian Federation: 91
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Turkey: 51
    Country: Number of subjects enrolled
    United States: 507
    Worldwide total number of subjects
    1301
    EEA total number of subjects
    311
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    879
    From 65 to 84 years
    422
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment included: United States (113 centers), Japan (22), Italy (18), Germany (16), China (13), Spain (9), France (7), Turkey (6), Austria (4), Belgium (4), Czech Republic (4), Greece (4), Israel (4), Poland (4), Republic of Korea (4), Russia (4), Australia (3), Finland (3), Norway (2), Sweden (2), Brazil (2), Denmark (1)

    Pre-assignment
    Screening details
    		 Participants in this study included: a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma, or fallopian tube cancer. Patients who were to undergo primary tumor reductive surgeryhad to have International Federation of Gynecological Oncologists Stage III with gross residual disease or Stage IV.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab
    Arm 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion was administered on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles.

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab was administered at a dose of 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule.

    Investigational medicinal product name
    Atezolizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab placebo was administered by IV infusion at a fixed dose of 1200mg on Day 1 of each 21-day cycle for 22cycles total or until disease progression, unacceptable toxicity, patient or physician’s decision to discontinue, patient death, or study termination by the Sponsor

    Arm title
    		 Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Arm description
    		 Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion was administered on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    Tecentriq
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab was administered by IV infusion at a fixed dose of 1200mg on Day 1 of each 21-day cycle for 22 cycles total or until disease progression, unacceptable toxicity, patient or physician’s decision to discontinue, patient death, or study termination by the Sponsor.

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab was administered at a dose of 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles.

    Number of subjects in period 1
    		Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Started
    650
    651
    Completed
    0
    0
    Not completed
    650
    651
         Consent withdrawn by subject
    45
    51
         Physician decision
    1
    3
         Protocol Deviation
    1
    4
         Study Terminated By Sponsor
    305
    311
         Death
    289
    272
         Lost to follow-up
    9
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    Reporting 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.

    Reporting group title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Reporting group description
    		 Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

    Reporting group values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Total
    Number of subjects
    		 650 651 1301
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 429 450 879
        From 65-84 years
    		 221 201 422
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 59.3 ( 10.7 ) 58.9 ( 10.5 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 650 651 1301
        Male
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 6 5 11
        Asian
    		 155 150 305
        Native Hawaiian or Other Pacific Islander
    		 0 2 2
        Black or African American
    		 13 8 21
        White
    		 461 464 925
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 15 22 37
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 38 39 77
        Not Hispanic or Latino
    		 598 589 1187
        Unknown or Not Reported
    		 14 23 37

    End points

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    End points reporting groups
    Reporting group title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    Reporting 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.

    Reporting group title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Reporting group description
    		 Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

    Primary: 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

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    End point 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
    End point 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.
    End point type
    Primary
    End point timeframe
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    650
    651
    Units: Months
        median (confidence interval 95%)
    18.37 (17.22 to 19.75)
    19.48 (18.14 to 20.76)
    Statistical analysis title
    		 PFS in ITT Population
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    1301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2785
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.07

    Primary: PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death−Ligand 1 (PD-L1)−Positive Subpopulation

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    End point title
    		 PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death−Ligand 1 (PD-L1)−Positive Subpopulation
    End point 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.
    End point type
    Primary
    End point timeframe
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    393
    391
    Units: Months
        median (confidence interval 95%)
    18.50 (16.62 to 21.36)
    20.83 (19.06 to 24.21)
    Statistical analysis title
    		 PFS in PD-L1-Positive Subpopulation
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    784
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0376
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.99
    Notes
    [1] - Stratified Analysis

    Primary: Overall Survival - ITT Population

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    End point title
    		 Overall Survival - ITT Population
    End point description
    Overall Survival (OS) is defined as the time from randomization to death from any cause. Note: 999999=not estimable.
    End point type
    Primary
    End point timeframe
    From randomization up to death from any cause (up to approximately 59 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    650
    651
    Units: Months
        median (confidence interval 95%)
    46.59 (45.31 to 49.74)
    50.53 (46.26 to 999999)
    Statistical analysis title
    		 OS in ITT Population
    Statistical analysis description
    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).
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    1301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.3432
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.09
    Notes
    [2] - Stratified Analysis

    Primary: Overall Survival - PD-L1−Positive Subpopulation

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    End point title
    		 Overall Survival - PD-L1−Positive Subpopulation
    End point description
    Overall Survival (OS) is defined as the time from randomization to death from any cause. Note: 999999=not estimable.
    End point type
    Primary
    End point timeframe
    From randomization up to death from any cause (up to approximately 59 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    393
    391
    Units: Months
        median (confidence interval 95%)
    49.15 (45.54 to 999999)
    999999 (999999 to 999999)
    Statistical analysis title
    		 OS in PD-L1-Positive Subpopulation
    Statistical analysis description
    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).
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    784
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.1316
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.06
    Notes
    [3] - Stratified Analysis

    Secondary: Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population

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    End point title
    		 Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
    End point 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.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    650
    651
    Units: Percentage of participants
        number (not applicable)
    88.7
    92.8
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    393
    391
    Units: Percentage of participants
        number (not applicable)
    89.9
    92.3
    No statistical analyses for this end point

    Secondary: Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population

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    End point title
    		 Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
    End point 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.
    End point type
    Secondary
    End point timeframe
    From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    650
    651
    Units: Months
        median (confidence interval 95%)
    14.06 (13.01 to 16.62)
    16.59 (14.52 to 19.09)
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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.
    End point type
    Secondary
    End point timeframe
    From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    650
    651
    Units: Months
        median (confidence interval 95%)
    13.44 (12.71 to 19.29)
    17.71 (15.01 to 19.61)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group

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    End point title
    		 Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
    End point 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). Note: n=participants with data at given timepoint. C=Cycle, D=Day, CoT=Completion of Treatment, FU=Follow Up, ETV=Early Termination Visit.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    157
    152
    Units: Percentage of participants
    number (not applicable)
        Abdominal Pain, Presurgical/Surgery (n=142,n=136)
    54.2
    50.7
        Abdominal Pain, C4D1 (n=140,n=133)
    36.4
    32.3
        Abdominal Pain, C6D1 (n=131,n=133)
    55.0
    48.1
        Abdominal Pain, C8D1 (n=129,n=122)
    64.3
    54.1
        Abdominal Pain, C12D1 (n=111,n=101)
    63.1
    57.4
        Abdominal Pain, C16D1 (n=96,n=88)
    63.5
    58.0
        Abdominal Pain, C20D1(n=83,n=62)
    68.7
    48.4
        Abd. Pain, CoT/ETV (n=143,n=130)
    51.0
    51.5
        Abdominal Pain, PT FU 3 Months (n=96,n=96 )
    58.3
    51.0
        Abdominal Pain, PT FU 6 Months (n=75,n=74)
    61.3
    51.4
        Abdominal Pain, PT FU 9 Months (n=73,n=38)
    60.5
    50.0
        Abdominal Pain, PT FU 12 Months (n=17,n=24 )
    70.6
    58.3
        Abdominal Pain, PT FU 18 Months
    100
    50.0
        Abdominal Pain, PT FU 24 Months (n=1,n=2)
    100
    100
        Bloating, Presurgical/Surgery (n=142,n=137)
    62.7
    54.0
        Bloating, C4D1 (n=140,n=132 )
    65.0
    59.8
        Bloating, C6D1 (n=131,n=133)
    71.0
    66.9
        Bloating, C8D1 (n=128,n=123)
    71.9
    63.4
        Bloating, C12D1 (n=111,n=101)
    68.5
    63.4
        Bloating, C16D1 (n=96,n=88 )
    66.7
    64.8
        Bloating, C20D1 (n=83,n=62 )
    66.3
    56.5
        Bloating, CoT/ETV (n=145,n=130)
    62.1
    58.5
        Bloating, PT FU 3 Months (n=96,n=96)
    57.3
    53.1
        Bloating, PT FU 6 Months (n=76,n=74)
    59.2
    62.2
        Bloating, PT FU 9 Months (n=43,n=38)
    67.4
    63.2
        Bloating, PT FU 12 Months (n=17,n=24)
    47.1
    62.5
        Bloating, PT FU 18 Months (n=6,n=4)
    66.7
    50.0
        Bloating, PT FU 24 Months (n=1,n=2)
    0
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group

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    End point title
    		 Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
    End point 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). Note: n=participants with data at given timepoint. C=Cycle, D=Day, ETV= Early Termination Vist, FU=Follow Up, CoT=Completion of Treatment, PT=Post Treatment.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    157
    152
    Units: Percentage of participants
    number (not applicable)
        Physical Func., Presurgical/Surgery (n=142,n=137)
    35.9
    33.6
        Physical Functioning, C4D1 (n=141,n=133)
    28.4
    18.0
        Physical Functioning, C6D1 (n=132,n=133)
    35.6
    25.6
        Physical Functioning, C8D1 (n=129, n=123)
    37.2
    36.6
        Physical Functioning, C12D1 (n=111,n=102)
    45.9
    43.1
        Physical Functioning, C16D1 (n=96, n=88)
    42.7
    42.0
        Physical Functioning, C20D1 (n=83,n=63)
    41.0
    31.7
        Physical Funct., CoT/ETV (n=144,n=131)
    38.9
    34.4
        Physical Funct., PT FU 3 Months (n=97,n=97)
    37.1
    39.2
        Physical Funct., PT FU 6 Months (n=76,n=74)
    40.8
    39.2
        Physical Funct., PT FU 9 Months (n=43,n=38)
    32.6
    50.0
        Physical Funct., PT FU 12 Months (n=17,n=24)
    23.5
    37.5
        Physical Funct., PT FU 18 Months (n=6,n=4)
    33.3
    50.0
        Physical Funct., PT FU 24 Months (n=1,n=2)
    100
    50.0
        Role Func., Presurgical/Surgery (n=142,n=137)
    48.6
    40.9
        Role Functioning, C4D1 (n=141,n=133)
    38.3
    22.6
        Role Functioning, C6D1 (n=133,n=134)
    45.9
    33.6
        Role Functioning, C8D1 (n=129,n=123)
    50.4
    39.8
        Role Functioning, C12D1 (n=111,n=102)
    55.9
    47.1
        Role Functioning, C16D1 (n=96,n=88)
    53.1
    46.6
        Role Functioning, C20D1 (n=83,n=63)
    56.6
    52.4
        Role Funct., CoT/ETV (n=145,n=131)
    46.9
    39.7
        Role Funct., PT FU 3 Months (n=97,n=97)
    49.5
    40.2
        Role Funct., PT FU 6 Months (n=76,n=74)
    51.3
    48.6
        Role Funct., PT FU 9 Months (n=43,n=38)
    53.5
    52.6
        Role Funct., PT FU 12 Months (n=17,n=24)
    23.5
    54.2
        Role Funct., PT FU 18 Months (n=6,n=4)
    50.0
    50.0
        Role Funct., PT FU 24 Months (n=1,n=2)
    0
    50.0
        Social Func., Presurgical/Surgery (n=142,n=137)
    32.4
    33.6
        Social Functioning, C4D1 (n=141,n=133)
    31.2
    25.6
        Social Functioning, C6D1 (n=133,n=132)
    36.8
    33.3
        Social Functioning, C8D1 (n=129,n=122)
    40.3
    39.3
        Social Functioning, C12D1 (n=111,n=101)
    39.6
    44.6
        Social Functioning, C16D1 (n=95,n=88)
    40.0
    44.3
        Social Functioning, C20D1 (n=83,n=62)
    45.8
    43.5
        Social Funct., CoT/ETV (n=144,n=130)
    40.3
    41.5
        Social Funct., PT FU 3 Months (n=96,n=96)
    42.7
    44.8
        Social Funct., PT FU 6 Months (n=76,n=74)
    46.1
    35.1
        Social Funct., PT FU 9 Months (n=43,n=38)
    46.5
    47.4
        Social Funct., PT FU 12 Months (n=17,n=24)
    29.4
    54.2
        Social Funct., PT FU 18 Months (n=6,n=4)
    66.7
    75.0
        Social Funct., PT FU 24 Months (n=1,n=2)
    0
    50.0
        Emotional Func., Presurgical/Surgery (n=142,n=137)
    31.7
    30.7
        Emotional Functioning, C4D1 (n=141,n=132)
    31.2
    35.6
        Emotional Functioning, C6D1 (n=133,n=131)
    42.1
    38.2
        Emotional Functioning, C8D1 (n=129,n=123)
    39.5
    44.7
        Emotional Functioning, C12D1 (n=111,n=101)
    41.4
    41.6
        Emotional Functioning, C16D1 (n=96,n=88)
    44.8
    42.0
        Emotional Functioning, C20D1 (n=83,n=62)
    44.6
    32.3
        Emotional Funct.,CoT/ETV (n=145,n=130)
    33.8
    33.8
        Emotional Funct., PT FU 3 months (n=96,n=96)
    35.4
    33.3
        Emotional Funct., PT FU 6 months (n=76,n=74)
    30.3
    33.8
        Emotional Funct., PT FU 9 months (n=43,n=38)
    39.5
    34.2
        Emotional Func., PT FU 12 months (n=17,n=24)
    29.4
    29.2
        Emotional Func., PT FU 18 months (n=6,n=4)
    16.7
    50.0
        Emotional Func., PT FU 24 months (n=1,n=2)
    0
    50.0
        GHS/HRQoL, PresurgicalSurgery (n=142,n=137)
    44.4
    46.7
        GHS/HRQoL, C4D1 (n=141,n=132)
    43.3
    37.1
        GHS/HRQoL, C6D1 (n=133,n=132)
    51.1
    47.7
        GHS/HRQoL, C8D1 (n=129,n=122)
    55.0
    59.0
        GHS/HRQoL, C12D1 (n=111,n=101)
    60.4
    61.4
        GHS/HRQoL, C16D1 (n=96,n=88)
    53.1
    58.0
        GHS/HRQoL, C20D1 (n=83,n=62)
    59.0
    61.3
        GHS/HRQoL, CoT/ ETV (n=145,n=130)
    46.9
    53.1
        GHS/HRQoL, PT FU 3 Months (n=95,n=96)
    53.7
    53.1
        GHS/HRQoL, PT FU 6 Months (n=76,n=74)
    48.7
    41.9
        GHS/HRQoL, PT FU 9 Months (n=43,n=38)
    39.5
    50.0
        GHS/HRQoL, PT FU 12 Months (n=17,n=24)
    17.6
    41.7
        GHS/HRQoL, PT FU 18 Months (n=6,n=4)
    16.7
    50.0
        GHS/HRQoL, PT FU 24 Months (n=1,n=2)
    0
    50.0
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Presurgical/Surgery
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.9096
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.62
    Notes
    [4] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 4 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.4662
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.01
    Notes
    [5] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 6 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    P-value
    		 = 0.5237
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.4
    Notes
    [6] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.3826
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.07
    Notes
    [7] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    P-value
    		 = 0.9893
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.76
    Notes
    [8] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.6892
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.61
    Notes
    [9] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.1324
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.17
    Notes
    [10] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Completion of Treatment/Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.9176
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.7
    Notes
    [11] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    P-value
    		 = 0.7861
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.68
    Notes
    [12] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 0.4539
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 2.65
    Notes
    [13] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    P-value
    		 = 0.4849
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.86
    Notes
    [14] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [15]
    P-value
    		 = 0.747
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 3.34
    Notes
    [15] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    P-value
    		 = 0.0896
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.86
         upper limit
    		 100
    Notes
    [16] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -94.3
         upper limit
    		 100
    Notes
    [17] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Presurgical/Surgery
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    P-value
    		 = 0.7347
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.5
    Notes
    [18] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Cycle 4 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [19]
    P-value
    		 = 0.0479
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1
    Notes
    [19] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Cycle 6 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [20]
    P-value
    		 = 0.0712
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.05
    Notes
    [20] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [21]
    P-value
    		 = 0.8168
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.58
    Notes
    [21] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [22]
    P-value
    		 = 0.6417
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.52
    Notes
    [22] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [23]
    P-value
    		 = 0.8821
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.72
    Notes
    [23] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    P-value
    		 = 0.2158
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.3
    Notes
    [24] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Completion of Treatment/Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4762
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.37
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [25]
    P-value
    		 = 0.7585
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.96
    Notes
    [25] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    P-value
    		 = 0.9985
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.93
    Notes
    [26] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [27]
    P-value
    		 = 0.1067
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 5.06
    Notes
    [27] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    P-value
    		 = 0.6171
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 5.61
    Notes
    [28] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [29]
    P-value
    		 = 0.8084
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 23.57
    Notes
    [29] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical Functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [30]
    P-value
    		 = 0.3173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    -50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 94.3
    Notes
    [30] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Presurgical/Surgery
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [31]
    P-value
    		 = 0.6802
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.77
    Notes
    [31] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 4 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [32]
    P-value
    		 = 0.347
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.29
    Notes
    [32] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 6 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [33]
    P-value
    		 = 0.5564
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.41
    Notes
    [33] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [34]
    P-value
    		 = 0.5
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.99
    Notes
    [34] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    P-value
    		 = 0.9778
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.78
    Notes
    [35] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [36]
    P-value
    		 = 0.6005
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 2.12
    Notes
    [36] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [37]
    P-value
    		 = 0.99
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 2
    Notes
    [37] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Completion of Treatment/Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [38]
    P-value
    		 = 0.2634
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 2.15
    Notes
    [38] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [39]
    P-value
    		 = 0.964
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.74
    Notes
    [39] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [40]
    P-value
    		 = 0.4117
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.46
    Notes
    [40] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [41]
    P-value
    		 = 0.3505
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 3.62
    Notes
    [41] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [42]
    P-value
    		 = 0.2439
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 9.45
    Notes
    [42] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [43]
    P-value
    		 = 0.1573
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.86
         upper limit
    		 100
    Notes
    [43] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [44]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -94.3
         upper limit
    		 100
    Notes
    [44] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role Functioning, Presurgical/Surgery
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [45]
    P-value
    		 = 0.182
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.16
    Notes
    [45] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 4 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [46]
    P-value
    		 = 0.0046
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 0.8
    Notes
    [46] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 6 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [47]
    P-value
    		 = 0.0361
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.97
    Notes
    [47] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [48]
    P-value
    		 = 0.0848
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.06
    Notes
    [48] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [49]
    P-value
    		 = 0.1224
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.13
    Notes
    [49] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [50]
    P-value
    		 = 0.3127
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.33
    Notes
    [50] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [51]
    P-value
    		 = 0.6065
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.65
    Notes
    [51] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [52]
    P-value
    		 = 0.2173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.2
    Notes
    [52] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [53]
    P-value
    		 = 0.1316
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.15
    Notes
    [53] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [54]
    P-value
    		 = 0.7678
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.76
    Notes
    [54] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [55]
    P-value
    		 = 0.7331
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 2.14
    Notes
    [55] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [56]
    P-value
    		 = 0.1235
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 10.92
    Notes
    [56] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [57]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -84.09
         upper limit
    		 84.09
    Notes
    [57] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [58]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -94.3
         upper limit
    		 100
    Notes
    [58] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Presurgical/Surgery
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [59]
    P-value
    		 = 0.7869
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.78
    Notes
    [59] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 4 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [60]
    P-value
    		 = 0.2502
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.25
    Notes
    [60] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 6 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [61]
    P-value
    		 = 0.5066
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.41
    Notes
    [61] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [62]
    P-value
    		 = 0.8124
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.59
    Notes
    [62] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [63]
    P-value
    		 = 0.4656
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.17
    Notes
    [63] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [64]
    P-value
    		 = 0.6725
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 2.12
    Notes
    [64] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [65]
    P-value
    		 = 0.578
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.64
    Notes
    [65] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Completion of Treatment/Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [66]
    P-value
    		 = 0.7611
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.76
    Notes
    [66] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [67]
    P-value
    		 = 0.7588
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.94
    Notes
    [67] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [68]
    P-value
    		 = 0.1428
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.19
    Notes
    [68] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [69]
    P-value
    		 = 0.9802
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 2.39
    Notes
    [69] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [70]
    P-value
    		 = 0.1967
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 8.7
    Notes
    [70] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [71]
    P-value
    		 = 0.4795
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Respnders
    Point estimate
    8.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -69.28
         upper limit
    		 85.94
    Notes
    [71] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 [72]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -94.3
         upper limit
    		 100
    Notes
    [72] - Stratified Analysis

    Secondary: Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    End point 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. Note: n=participants with data at given timepoint. C=Cycle, D=Day, ETV= Early Termination Visit, FU=Follow Up, CoT=Completion of Treatment, PT=Post Treatment.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    473
    473
    Units: Percentage of participants
    number (not applicable)
        Physical Functioning, C3D1 (n=456, n=444)
    22.6
    19.8
        Physical Functioning, C5D1 (n=439,n=423)
    23.7
    21.3
        Physical Functioning, C8D1 (n=414,n=403)
    28.7
    27.0
        Physical Functioning, C12D1 (n=378,n=358)
    35.4
    32.4
        Physical Functioning, C16D1 (n=333,n=312)
    32.1
    34.3
        Physical Functioning, C20D1 (n=253,n=234)
    34.8
    32.5
        Physical Func., CoT/ETV (n=370,n=366)
    32.4
    30.3
        Physical Func., PT FU 3 Months (n=235,n=236)
    35.7
    28.4
        Physical Func., PT FU 6 Months (n=147,n=164)
    32.7
    31.1
        Physical Func., PT FU 9 Months (n=84,n=98)
    34.5
    27.6
        Physical Func., PT FU 12 Months (n=45,n=58)
    37.8
    24.1
        Physical Func., PT FU 18 Months (n=14,n=16)
    42.9
    18.8
        Physical Func., PT FU 24 Months (n=2,n=6)
    0
    16.7
        Role Functioning, C3D1 (n=455,n=443)
    42.6
    40.9
        Role Functioning, C5D1 (n=438,n=422)
    42.9
    38.9
        Role Functioning, C8D1 (n=413,n=401)
    47.5
    45.9
        Role Functioning, C12D1 (n=377,n=358)
    50.1
    50.6
        Role Functioning, C16Day1 (n=333,n=311)
    52.0
    50.8
        Role Functioning, C20D1 (n=253,n=233)
    53.8
    51.5
        Role Func.,CoT/ETV (n=370,n=367)
    48.4
    46.6
        Role Func., PT FU 3 Months (n=235,n=236)
    54.0
    45.3
        Role Func., PT FU 6 Months (n=147,n=164)
    55.1
    43.9
        Role Func., PT FU 9 Months (n=84,n=98)
    57.1
    38.8
        Role Func., PT FU 12 Months (n=45,n=58)
    60
    27.6
        Role Func., PT FU 18 Months (n=14,n=16)
    50
    43.8
        Role Func., PT FU 24 Months (n=2,n=6)
    50
    16.7
        Social Functioning, C3D1 (n=455,n=442)
    30.1
    31.4
        Social Functioning, C5D1 (n=439,n=422)
    32.6
    32.0
        Social Functioning, C8D1 (n=413,n=403)
    37.8
    38.7
        Social Functioning, C12D1 (n=376,n=357)
    42.6
    41.2
        Social Functioning, C16D1 (n=333,n=312)
    43.5
    48.7
        Social Functioning, C20D1 (n=252,n=234)
    45.6
    50.0
        Social Func, CoT/ETV
    40.6
    40.1
        Social Func, PT FU 3 Months (n=367,n=367)
    42.7
    41.1
        Social Func., PT FU 6 Months (n=234,n=236)
    43.2
    34.1
        Social Func., PT FU 9 Months (n=148,n=164)
    50.0
    36.7
        Social Func, PT FU 12 Months (n=84,n=98)
    62.2
    36.2
        Social Func., PT FU 18 Months (n=14,n=16)
    57.1
    43.8
        Social Func., PT FU 24 Months (n=2,n=6)
    100
    50.0
        Emotional Functioning, C3D1 (n=454,n=443)
    29.7
    28.4
        Emotional Functioning, C5D1 (n=439,n=422)
    30.3
    30.3
        Emotional Functioning, C8D1 (n=412,n=403)
    32.3
    33.0
        Emotional Functioning, C12D1 (n=376,n=357)
    34.6
    36.1
        Emotional Functioning, C16D1 (n=333,n=312)
    31.8
    35.9
        Emotional Functioning, C20D1 (n=252,n=234)
    35.3
    36.8
        Emotional Func., CoT/ETV (n=368,n=367)
    27.7
    28.6
        Emotional Func., PT FU 3 Months (n=234,n=236)
    29.1
    27.5
        Emotional Func., PT FU 6 Months (n=148,n=164)
    30.4
    37.8
        Emotional Func., PT FU 9 Months (n=84,n=98)
    38.1
    33.7
        Emotional Func., PT FU 12 Months (n=45,n=58)
    44.4
    34.5
        Emotional Func., PT FU 18 Months (n=14,n=16)
    42.9
    31.3
        Emotional Func., PT FU 24 Months (n=2,n=6)
    50.0
    16.7
        GHS/OoL, C3D1 (n=455,n=443)
    32.3
    34.5
        GHS/OoL, C5D1 (n=439,n=422)
    33.0
    31.0
        GHS/OoL, C8D1 (n=413,n=403)
    39.5
    38.7
        GHS/OoL, C12D1 (n=376,n=357)
    41.5
    43.4
        GHS/OoL, C16D1 (n=333,n=312)
    42.9
    42.9
        GHS/OoL, C20D1 (n=252,n=234)
    42.5
    46.2
        GHS/OoL,CoT/ETV (n=368,n=367)
    38.0
    34.9
        GHS/OoL, PT FU 3 Months (n=234,n=236)
    40.6
    38.6
        GHS/OoL, PT FU 6 Months (n=148,n=164)
    39.2
    34.1
        GHS/OoL, PT FU 9 Months (n=84,n=98)
    39.3
    35.7
        GHS/OoL, PT FU 12 Months (n=45,n=58)
    40.0
    32.8
        GHS/OoL, PT FU 18 Months (n=14,n=16)
    42.9
    18.8
        GHS/OoL, PT FU 24 Months (n=2,n=6)
    100
    33.3
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [73]
    P-value
    		 = 0.6651
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.25
    Notes
    [73] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [74]
    P-value
    		 = 0.9927
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.34
    Notes
    [74] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [75]
    P-value
    		 = 0.8209
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.39
    Notes
    [75] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [76]
    P-value
    		 = 0.6507
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.45
    Notes
    [76] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [77]
    P-value
    		 = 0.2596
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.67
    Notes
    [77] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [78]
    P-value
    		 = 0.6532
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.58
    Notes
    [78] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Completion Of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [79]
    P-value
    		 = 0.7592
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.45
    Notes
    [79] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [80]
    P-value
    		 = 0.7424
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.4
    Notes
    [80] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [81]
    P-value
    		 = 0.1912
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 2.19
    Notes
    [81] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [82]
    P-value
    		 = 0.5526
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.53
    Notes
    [82] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [83]
    P-value
    		 = 0.3609
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.52
    Notes
    [83] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [84]
    P-value
    		 = 0.7527
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 3.23
    Notes
    [84] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [85]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    -33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 75.44
    Notes
    [85] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [86]
    P-value
    		 = 0.3177
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.17
    Notes
    [86] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [87]
    P-value
    		 = 0.4184
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.21
    Notes
    [87] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [88]
    P-value
    		 = 0.3973
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.19
    Notes
    [88] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [89]
    P-value
    		 = 0.571
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.24
    Notes
    [89] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [90]
    P-value
    		 = 0.5163
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.55
    Notes
    [90] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [91]
    P-value
    		 = 0.6897
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.35
    Notes
    [91] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Completion Of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [92]
    P-value
    		 = 0.5735
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.25
    Notes
    [92] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [93]
    P-value
    		 = 0.8655
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.55
    Notes
    [93] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [94]
    P-value
    		 = 0.1414
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.1
    Notes
    [94] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [95]
    P-value
    		 = 0.3017
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.35
    Notes
    [95] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [96]
    P-value
    		 = 0.2325
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.39
    Notes
    [96] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [97]
    P-value
    		 = 0.1717
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 1.69
    Notes
    [97] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [98]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.49
         upper limit
    		 79.82
    Notes
    [98] - Stratified Analsyis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [99]
    P-value
    		 = 0.4745
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.46
    Notes
    [99] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [100]
    P-value
    		 = 0.5499
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.22
    Notes
    [100] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [101]
    P-value
    		 = 0.8436
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.29
    Notes
    [101] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [102]
    P-value
    		 = 0.5798
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.46
    Notes
    [102] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [103]
    P-value
    		 = 0.9094
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.39
    Notes
    [103] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [104]
    P-value
    		 = 0.4006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.67
    Notes
    [104] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [105]
    P-value
    		 = 0.4024
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.19
    Notes
    [105] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [106]
    P-value
    		 = 0.8796
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.41
    Notes
    [106] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [107]
    P-value
    		 = 0.435
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.32
    Notes
    [107] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [108]
    P-value
    		 = 0.6225
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.56
    Notes
    [108] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [109]
    P-value
    		 = 0.5775
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.77
    Notes
    [109] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [110]
    P-value
    		 = 0.2343
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 1.94
    Notes
    [110] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [111]
    P-value
    		 = 0.0833
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    -66.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 4.39
    Notes
    [111] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [112]
    P-value
    		 = 0.6012
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.21
    Notes
    [112] - Superiority
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [113]
    P-value
    		 = 0.2291
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.11
    Notes
    [113] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [114]
    P-value
    		 = 0.6574
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.24
    Notes
    [114] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [115]
    P-value
    		 = 0.9217
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.35
    Notes
    [115] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [116]
    P-value
    		 = 0.7693
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.3
    Notes
    [116] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [117]
    P-value
    		 = 0.647
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.31
    Notes
    [117] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Completion Of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [118]
    P-value
    		 = 0.6391
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.25
    Notes
    [118] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [119]
    P-value
    		 = 0.0892
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.05
    Notes
    [119] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [120]
    P-value
    		 = 0.055
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.01
    Notes
    [120] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [121]
    P-value
    		 = 0.0168
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 0.88
    Notes
    [121] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [122]
    P-value
    		 = 0.7817
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 3.8
    Notes
    [122] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [123]
    P-value
    		 = 0.0021
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.65
    Notes
    [123] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [124]
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    -33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 75.44
    Notes
    [124] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [125]
    P-value
    		 = 0.6646
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.41
    Notes
    [125] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [126]
    P-value
    		 = 0.8677
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.3
    Notes
    [126] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [127]
    P-value
    		 = 0.767
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.38
    Notes
    [127] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7487
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.28
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [128]
    P-value
    		 = 0.1882
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.68
    Notes
    [128] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3015
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.72
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [129]
    P-value
    		 = 0.9059
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.32
    Notes
    [129] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7125
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.35
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [130]
    P-value
    		 = 0.0947
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.07
    Notes
    [130] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [131]
    P-value
    		 = 0.0686
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.05
    Notes
    [131] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [132]
    P-value
    		 = 0.3376
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 2.3
    Notes
    [132] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [133]
    P-value
    		 = 0.0175
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.86
    Notes
    [133] - Stratified Analysis
    Statistical analysis title
    		 Clinically-Meaningful Improvement
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5637
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    -50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 23.34

    Secondary: Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    End point description
    Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30. Note: n=participants with data at given timepoint. C=Cycle, D=Day, ETV= Early Termination Visit, FU=Follow Up, CoT=Completion of Treatment, PT=Post Treatment.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    473
    473
    Units: Percentage of participants
    number (not applicable)
        Physical Functioning, C3D1 (n=456, n=444)
    53.1
    56.1
        Physical Functioning, C5D1 (n=439, n=423)
    49.0
    50.1
        Physical Functioning, C8D1 (n=414, n=403)
    47.8
    49.4
        Physical Functioning, C12D1 (n=378, n=358)
    47.1
    51.1
        Physical Functioning, C16D1 (n=333, n=312)
    50.5
    48.7
        Physical Functioning, C20D1 (n=253, n=234)
    46.6
    50.9
        Physical Func., CoT/ETV (n=370, n=366)
    46.8
    44.5
        Physical Func., PT FU 3 Months (n=235, n=236)
    41.3
    47.9
        Physical Func., PT FU 6 Months (n=147, n=164)
    42.2
    43.9
        Physical Funct., PT FU 9 Months (n=84, n=98)
    46.4
    46.9
        Physical Func., PT FU 12 Months (n=45, n=58)
    44.4
    50.0
        Physical Func., PT FU 18 Months (n=14, n=16)
    35.7
    56.3
        Physical Func., PT FU 24 Months (n=2, n=6)
    100
    33.3
        Role Functioning, C3D1 (n=455, n=443)
    35.8
    30.9
        Role Functioning, C5D1 (n=438, n=422)
    30.1
    33.6
        Role Functioning, C8D1 (n=413, n=401)
    31.2
    30.9
        Role Functioning, C12D1 (n=377, n=358)
    32.9
    32.1
        Role Functioning, C16D1 (n=333, n=311)
    27.6
    33.4
        Role Functioning, C20D1 (n=253, n=233)
    27.3
    34.8
        Role Func., CoT/ETV (n=370, n=367)
    28.6
    28.6
        Role Func., PT FU 3 Months (n=235, n=236)
    25.1
    27.1
        Role Func., PT FU 6 Months (n=147, n=164)
    24.5
    29.9
        Role Func., PT FU 9 Months (n=84, n=98)
    23.8
    34.7
        Role Func., PT FU 12 Months (n=45, n=58)
    33.3
    34.5
        Role Func., PT FU 18 Months (n=14, n=16)
    42.9
    25.0
        Role Func., PT FU 24 Months (n=2, n=6)
    50
    66.7
        Social Functioning, C3D1 (n=455, n=442)
    40.7
    36.7
        Social Functioning, C5D1 (n=439, n=422)
    37.6
    36.7
        Social Functioning, C8D1 (n=413, n=403)
    40.2
    35.2
        Social Functioning, C12D1 (n=376, n=357)
    38.3
    39.2
        Social Functioning, C16D1 (n=333, n=312)
    36.6
    33.3
        Social Functioning, C20D1 (n=252, n=234)
    34.1
    33.8
        Social Func.,CoT/ETV (n=367, n=367)
    31.9
    31.1
        Social Func., PT FU 3 Months (n=234, n=236)
    30.3
    32.6
        Social Func., PT FU 6 Months (n=148, n=164)
    33.8
    34.8
        Social Func., PT FU 9 Months (n=84, n=98)
    27.4
    30.6
        Social Func., PT FU 12 Months (n=45, n=58)
    28.9
    25.9
        Social Func., PT FU 18 Months (n=14, n=16)
    28.6
    18.8
        Social Func., PT FU 24 Months (n=2, n=6)
    0
    16.7
        Emotional Functioning, C3D1 (n=454, n=443)
    57.5
    57.3
        Emotional Functioning, C5D1 (n=439, n=422)
    52.4
    53.6
        Emotional Functioning, C8D1 (n=412, n=403)
    53.2
    54.6
        Emotional Functioning, C12D1 (n=376, n=357)
    53.2
    50.1
        Emotional Functioning, C16D1 (n=333, n=312)
    55.0
    51.3
        Emotional Functioning, C20D1 (n=252, n=234)
    49.2
    52.1
        Emotional Func., CoT/ETV (n=368, n=367)
    53.0
    51.8
        Emotional Func., PT FU 3 Months (n=234, n=236)
    51.3
    55.5
        Emotional Func., PT FU 6 Months (n=148, n=164)
    48.6
    47.6
        Emotional Func., PT FU 9 Months (n=84, n=98)
    53.6
    48.0
        Emotional Func., PT FU 12 Months (n=45, n=58)
    46.7
    43.1
        Emotional Func., PT FU18 Months (n=14, n=16)
    50.0
    37.5
        Emotional Func., PT FU 24 Months (n=2, n=6)
    50.0
    16.7
        GHS/OoL, C3D1 (n=455, n=443)
    43.3
    42.2
        GHS/OoL, C5D1 (n=439, n=422)
    42.6
    44.8
        GHS/OoL, C8D1 (n=413, n=403)
    39.0
    42.9
        GHS/OoL, C12D1 (n=376, n=357)
    40.7
    42.9
        GHS/OoL, C16D1 (n=333, n=312)
    38.4
    43.3
        GHS/OoL, C20D1 (n=252, n=234)
    36.9
    42.3
        GHS/OoL, CoT/ETV (n=368, n=367)
    37.2
    40.3
        GHS/OoL, PT FU 3 Months (n=234, n=236)
    38.9
    38.6
        GHS/OoL, PT FU 6 Months (n=148, n=164)
    39.9
    42.1
        GHS/OoL, PT FU 9 Months (n=84, n=98)
    39.3
    38.8
        GHS/OoL, PT FU 12 Months (n=45, n=58)
    42.2
    32.8
        GHS/OoL, PT FU 18 Months (n=14, n=16)
    35.7
    37.5
        GHS/OoL, PT FU Up 24 Months (n=2, n=6)
    0
    16.7
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [134]
    P-value
    		 = 0.977
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.3
    Notes
    [134] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [135]
    P-value
    		 = 0.7317
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.37
    Notes
    [135] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6937
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.39
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [136]
    P-value
    		 = 0.3916
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.18
    Notes
    [136] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [137]
    P-value
    		 = 0.3363
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.17
    Notes
    [137] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [138]
    P-value
    		 = 0.6997
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.26
    Notes
    [138] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6761
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.55
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [139]
    P-value
    		 = 0.3592
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.72
    Notes
    [139] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [140]
    P-value
    		 = 0.8798
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.51
    Notes
    [140] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [141]
    P-value
    		 = 0.3857
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.39
    Notes
    [141] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [142]
    P-value
    		 = 0.6854
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.85
    Notes
    [142] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [143]
    P-value
    		 = 0.4533
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 2.7
    Notes
    [143] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Emotional Functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [144]
    P-value
    		 = 0.3173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    -33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 75.44
    Notes
    [144] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [145]
    P-value
    		 = 0.3658
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.47
    Notes
    [145] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [146]
    P-value
    		 = 0.7619
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.36
    Notes
    [146] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [147]
    P-value
    		 = 0.658
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.4
    Notes
    [147] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [148]
    P-value
    		 = 0.2726
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.57
    Notes
    [148] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [149]
    P-value
    		 = 0.6973
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.29
    Notes
    [149] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [150]
    P-value
    		 = 0.447
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.64
    Notes
    [150] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [151]
    P-value
    		 = 0.515
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.21
    Notes
    [151] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [152]
    P-value
    		 = 0.2103
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.82
    Notes
    [152] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [153]
    P-value
    		 = 0.7969
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.66
    Notes
    [153] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [154]
    P-value
    		 = 0.83
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.91
    Notes
    [154] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [155]
    P-value
    		 = 0.6987
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 2.55
    Notes
    [155] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [156]
    P-value
    		 = 0.1441
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 17.77
    Notes
    [156] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [157]
    P-value
    		 = 0.3173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportion of Responders
    Point estimate
    -66.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100
         upper limit
    		 4.39
    Notes
    [157] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [158]
    P-value
    		 = 0.7591
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.25
    Notes
    [158] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [159]
    P-value
    		 = 0.5403
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.42
    Notes
    [159] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [160]
    P-value
    		 = 0.2654
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.55
    Notes
    [160] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5138
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.48
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [161]
    P-value
    		 = 0.2138
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.67
    Notes
    [161] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [162]
    P-value
    		 = 0.2114
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.82
    Notes
    [162] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [163]
    P-value
    		 = 0.3938
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.53
    Notes
    [163] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [164]
    P-value
    		 = 0.7793
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.38
    Notes
    [164] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [165]
    P-value
    		 = 0.737
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.39
    Notes
    [165] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [166]
    P-value
    		 = 0.9658
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.79
    Notes
    [166] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [167]
    P-value
    		 = 0.3015
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 1.46
    Notes
    [167] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [168]
    P-value
    		 = 0.7534
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 3.94
    Notes
    [168] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Global health status/ QoL, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [169]
    P-value
    		 = 0.5637
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.49
         upper limit
    		 79.82
    Notes
    [169] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [170]
    P-value
    		 = 0.1177
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.06
    Notes
    [170] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [171]
    P-value
    		 = 0.273
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.56
    Notes
    [171] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [172]
    P-value
    		 = 0.9306
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.33
    Notes
    [172] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [173]
    P-value
    		 = 0.8631
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.32
    Notes
    [173] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [174]
    P-value
    		 = 0.0977
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.86
    Notes
    [174] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [175]
    P-value
    		 = 0.0726
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.1
    Notes
    [175] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [176]
    P-value
    		 = 0.9974
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.38
    Notes
    [176] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab v Placebo With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [177]
    P-value
    		 = 0.7069
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.63
    Notes
    [177] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [178]
    P-value
    		 = 0.3068
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 2.16
    Notes
    [178] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [179]
    P-value
    		 = 0.1375
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 3.16
    Notes
    [179] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [180]
    P-value
    		 = 0.954
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 2.29
    Notes
    [180] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [181]
    P-value
    		 = 0.4283
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.64
    Notes
    [181] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [182]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -95.56
         upper limit
    		 100
    Notes
    [182] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [183]
    P-value
    		 = 0.2153
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.1
    Notes
    [183] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [184]
    P-value
    		 = 0.7878
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.27
    Notes
    [184] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [185]
    P-value
    		 = 0.1544
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.08
    Notes
    [185] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [186]
    P-value
    		 = 0.8017
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.4
    Notes
    [186] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [187]
    P-value
    		 = 0.4295
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.21
    Notes
    [187] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [188]
    P-value
    		 = 0.954
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Log odds ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.44
    Notes
    [188] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [189]
    P-value
    		 = 0.7494
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.3
    Notes
    [189] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [190]
    P-value
    		 = 0.6412
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.62
    Notes
    [190] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [191]
    P-value
    		 = 0.8652
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.67
    Notes
    [191] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [192]
    P-value
    		 = 0.6912
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2.18
    Notes
    [192] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [193]
    P-value
    		 = 0.5834
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.86
    Notes
    [193] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [194]
    P-value
    		 = 0.9578
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 16.05
    Notes
    [194] - Stratified Analysis
    Statistical analysis title
    		 Remain Stable
    Statistical analysis description
    Social Functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [195]
    P-value
    		 = 0.5637
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.49
         upper limit
    		 79.82
    Notes
    [195] - Stratified Analysis

    Secondary: Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

    		 Close Top of page
    End point title
    		 Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    End point description
    Percentage of participants with deterioration in patient-reported function and HRQoL, defined as >= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30. Note: n=participants with data at given timepoint. C=Cycle, D=Day, ETV= Early Termination Visit, FU=Follow Up, CoT=Completion of Treatment, PT=Post Treatment.
    End point type
    Secondary
    End point timeframe
    From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    473
    473
    Units: Percentage of participants
    number (not applicable)
        Physical Functioning, C3D1 (n=456, n=444)
    24.1
    24.1
        Physical Functioning, C5D1 (n=439, n=423)
    27.1
    28.6
        Physical Functioning, C8D1 (n=414, n=403)
    23.4
    23.6
        Physical Functioning, C12D1 (n=378, n=358)
    17.2
    16.5
        Physical Functioning, C16D1 (n=333, n=312)
    17.1
    17.0
        Physical Functioning, C20D1 (n=253, n=234)
    18.2
    16.7
        Physical Func.,CoT/ETV (n=370, n=366)
    20.5
    25.1
        Physical Func., PT FU 3 Months (n=235, n=236)
    22.6
    23.7
        Physical Func., PT FU 6 Months (n=147, n=164)
    24.5
    25.0
        Physical Func., PT FU 9 Months (n=84, n=98)
    19.0
    25.5
        Physical Func., PT FU 12 Months (n=45, n=58)
    17.8
    25.9
        Physical Func., PT FU 18 Months (n=14, n=16)
    21.4
    25.0
        Physical Func., PT FU 24 Months (n=2, n=6)
    0
    50
        Role Functioning, C3D1 (n=455, n=443)
    21.3
    27.8
        Role Functioning, C5D1 (n=438, n=422)
    26.7
    27.0
        Role Functioning, C8D1 (n=413, n=401)
    21.1
    22.7
        Role Functioning, C12D1 (n=377, n=358)
    16.7
    16.8
        Role Functioning, C16D1 (n=333, n=311)
    20.1
    15.8
        Role Functioning, C20D1 (n=253, n=233)
    18.6
    13.3
        Role Func., CoT/ETV (n=370, n=367)
    23.0
    24.3
        Role Func., PT FU 3 Months (n=235, n=236)
    20.9
    27.1
        Role Func., PT FU 6 Months (n=147, n=164)
    20.4
    25.6
        Role Func., PT FU 9 Months (n=84, n=98)
    19.0
    26.5
        Role Func., PT FU 12 Months (n=45, n=58)
    6.7
    37.9
        Role Func., PT FU 18 Months (n=14, n=16)
    7.1
    31.3
        Role Func., PT FU 24 Months (n=2, n=6)
    0
    16.7
        Social Functioning, C3D1 (n=455, n=442)
    29.0
    31.2
        Social Functioning, C5D1 (n=439, n=422)
    29.6
    30.6
        Social Functioning, C8D1 (n=413, n=403)
    21.8
    25.8
        Social Functioning, C12D1 (n=376, n=357)
    18.9
    19.0
        Social Functioning, C16D1 (n=333, n=312)
    19.5
    17.6
        Social Functioning, C20D1 (n=252, n=234)
    20.2
    16.2
        Social Func., CoT/ETV (n=367, n=367)
    27.2
    28.1
        Social Func., PT FU 3 Months (n=234, n=236)
    26.5
    25.4
        Social Func., PT FU 6 Months (n=148, n=164)
    23.0
    30.5
        Social Func., PT FU 9 Months (n=84, n=98)
    22.6
    32.7
        Social Func., PT FU 12 Months (n=45, n=58)
    8.9
    37.9
        Social Func., PT FU 18 Months (n=14, n=16)
    14.3
    37.5
        Social Func., PT FU 24 Months (n=2, n=6)
    0
    33.3
        Emotional Functioning, C3D1 (n=454, n=443)
    12.8
    14.0
        Emotional Functioning, C5D1 (n=439, n=422)
    17.3
    15.9
        Emotional Functioning, C8D1 (n=412, n=403)
    14.6
    12.4
        Emotional Functioning, C12D1 (n=376, n=357)
    12.2
    13.4
        Emotional Functioning, C16D1 (n=333, n=312)
    13.2
    12.5
        Emotional Functioning, C20D1 (n=252, n=234)
    15.5
    11.1
        Emotional Func., CoT/ETV (n=368, n=367)
    19.3
    19.3
        Emotional Func., PT FU 3 Months (n=234, n=236)
    19.7
    16.9
        Emotional Func., PT FU 6 Months (n=148, n=164)
    20.9
    14.6
        Emotional Func., PT FU 9 Months (n=84, n=98)
    8.3
    18.4
        Emotional Func., PT FU 12 Months (n=45, n=58)
    8.9
    22.4
        Emotional Func., PT FU 18 Months (n=14, n=16)
    7.1
    31.3
        Emotional Func., PT FU 24 Months (n=2, n=6)
    0
    66.7
        GHS/OoL Function, C3D1 (n=455, n=443)
    24.2
    22.8
        GHS/OoL Function, C5D1 (n=439, n=422)
    24.1
    23.7
        GHS/OoL Function, C8D1 (n=413, n=403)
    21.3
    18.1
        GHS/OoL Function, C12D1 (n=376, n=357)
    17.6
    13.2
        GHS/OoL Function, C16D1 (n=333, n=312)
    18.3
    13.5
        GHS/OoL Function, C20D1 (n=252, n=234)
    20.2
    11.1
        GHS/OoL Func., CoT/ETV (n=368, n=367)
    24.5
    24.3
        GHS/OoL Func., PT FU 3 Months (n=234, n=236)
    20.5
    22.9
        GHS/OoL Func., PT FU 6 Months (n=148, n=164)
    20.9
    23.8
        GHS/OoL Func., PT FU 9 Months (n=84, n=98)
    21.4
    25.5
        GHS/OoL Func., PT FU 12 Months (n=45, n=58)
    17.8
    34.5
        GHS/OoL Func., PT FU 18 Months (n=14, n=16)
    21.4
    43.8
        GHS/OoL Func., PT FU 24 Months (n=2, n=6)
    0
    50.0
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [196]
    P-value
    		 = 0.6063
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.63
    Notes
    [196] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [197]
    P-value
    		 = 0.5739
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.29
    Notes
    [197] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [198]
    P-value
    		 = 0.3792
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.25
    Notes
    [198] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [199]
    P-value
    		 = 0.6022
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.73
    Notes
    [199] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [200]
    P-value
    		 = 0.7893
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.49
    Notes
    [200] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2125
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.22
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [201]
    P-value
    		 = 0.9661
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.46
    Notes
    [201] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [202]
    P-value
    		 = 0.4299
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.32
    Notes
    [202] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [203]
    P-value
    		 = 0.0363
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 6.76
    Notes
    [203] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [204]
    P-value
    		 = 0.1542
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.18
    Notes
    [204] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [205]
    P-value
    		 = 0.0814
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 8.93
    Notes
    [205] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [206]
    P-value
    		 = 0.1915
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 38
    Notes
    [206] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [207]
    P-value
    		 = 0.9818
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.35
    Notes
    [207] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Emotional functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [208]
    P-value
    		 = 0.3173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    66.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.39
         upper limit
    		 100
    Notes
    [208] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [209]
    P-value
    		 = 0.6263
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.45
    Notes
    [209] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [210]
    P-value
    		 = 0.9407
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.4
    Notes
    [210] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [211]
    P-value
    		 = 0.77
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.39
    Notes
    [211] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [212]
    P-value
    		 = 0.8458
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.45
    Notes
    [212] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [213]
    P-value
    		 = 0.7028
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.46
    Notes
    [213] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1391
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.83
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [214]
    P-value
    		 = 0.8002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.62
    Notes
    [214] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [215]
    P-value
    		 = 0.9751
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.68
    Notes
    [215] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [216]
    P-value
    		 = 0.3811
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 2.78
    Notes
    [216] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [217]
    P-value
    		 = 0.395
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 3.9
    Notes
    [217] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [218]
    P-value
    		 = 0.8993
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 5.12
    Notes
    [218] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Physical functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [219]
    P-value
    		 = 0.3173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.34
         upper limit
    		 100
    Notes
    [219] - Stratified
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [220]
    P-value
    		 = 0.5988
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.25
    Notes
    [220] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [221]
    P-value
    		 = 0.8859
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.34
    Notes
    [221] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [222]
    P-value
    		 = 0.2531
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.16
    Notes
    [222] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [223]
    P-value
    		 = 0.0785
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.04
    Notes
    [223] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [224]
    P-value
    		 = 0.0641
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.03
    Notes
    [224] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [225]
    P-value
    		 = 0.0046
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 0.8
    Notes
    [225] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [226]
    P-value
    		 = 0.8928
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.37
    Notes
    [226] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [227]
    P-value
    		 = 0.6106
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.74
    Notes
    [227] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [228]
    P-value
    		 = 0.6159
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.95
    Notes
    [228] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [229]
    P-value
    		 = 0.0845
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 5.58
    Notes
    [229] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [230]
    P-value
    		 = 0.5372
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 2.49
    Notes
    [230] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [231]
    P-value
    		 = 0.1344
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 21.56
    Notes
    [231] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Global health status/QoL, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [232]
    P-value
    		 = 0.3173
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.34
         upper limit
    		 100
    Notes
    [232] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [233]
    P-value
    		 = 0.9179
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.37
    Notes
    [233] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [234]
    P-value
    		 = 0.026
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.92
    Notes
    [234] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [235]
    P-value
    		 = 0.582
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.53
    Notes
    [235] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [236]
    P-value
    		 = 0.9772
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.47
    Notes
    [236] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [237]
    P-value
    		 = 0.13
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.1
    Notes
    [237] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [238]
    P-value
    		 = 0.099
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.08
    Notes
    [238] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [239]
    P-value
    		 = 0.7133
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.5
    Notes
    [239] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [240]
    P-value
    		 = 0.1384
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 2.11
    Notes
    [240] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [241]
    P-value
    		 = 0.2895
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 2.26
    Notes
    [241] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [242]
    P-value
    		 = 0.2221
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 3.14
    Notes
    [242] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [243]
    P-value
    		 = 0.0005
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.08
         upper limit
    		 26.1
    Notes
    [243] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [244]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    16.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.49
         upper limit
    		 79.82
    Notes
    [244] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Role functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2171
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 34.56
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Cycle 3 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [245]
    P-value
    		 = 0.4647
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.48
    Notes
    [245] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Cycle 5 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [246]
    P-value
    		 = 0.7676
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.4
    Notes
    [246] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Cycle 8 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [247]
    P-value
    		 = 0.1983
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.71
    Notes
    [247] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Cycle 12 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [248]
    P-value
    		 = 0.9874
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.44
    Notes
    [248] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Cycle 16 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [249]
    P-value
    		 = 0.4716
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.29
    Notes
    [249] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Cycle 20 Day 1
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [250]
    P-value
    		 = 0.2041
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.18
    Notes
    [250] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Completion of Treatment/ Early Termination Visit
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [251]
    P-value
    		 = 0.7771
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.45
    Notes
    [251] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 3 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [252]
    P-value
    		 = 0.8542
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.45
    Notes
    [252] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 6 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [253]
    P-value
    		 = 0.123
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 2.5
    Notes
    [253] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 9 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [254]
    P-value
    		 = 0.1089
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 3.34
    Notes
    [254] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 12 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [255]
    P-value
    		 = 0.0011
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.85
         upper limit
    		 18.3
    Notes
    [255] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 18 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [256]
    P-value
    		 = 0.295
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 14.74
    Notes
    [256] - Stratified Analysis
    Statistical analysis title
    		 Deterioration
    Statistical analysis description
    Social functioning, Post-Treatment Follow Up 24 Months
    Comparison groups
    Placebo With Paclitaxel, Carboplatin and Bevacizumab v Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects included in analysis
    946
    Analysis specification
    Pre-specified
    Analysis type
    		 [257]
    Method
    Parameter type
    		 Difference in Proportion of Responders
    Point estimate
    33.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.72
         upper limit
    		 100
    Notes
    [257] - Stratified Analysis

    Secondary: Percentage of Participants With at Least One Adverse Event

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    End point title
    		 Percentage of Participants With at Least One Adverse Event
    End point description
    Percentage of participants with at least one adverse event
    End point type
    Secondary
    End point timeframe
    From randomization up to approximately 59 months
    End point values
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    644
    642
    Units: Percentage
        number (not applicable)
    99.8
    100
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration (Cmax) of Atezolizumab

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    End point title
    		 Maximum Serum Concentration (Cmax) of Atezolizumab [258]
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
    Notes
    [258] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis for this endpoint.
    End point values
    		 Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    538
    Units: µg/mL
    arithmetic mean (standard deviation)
        Cycle 1 Day 1
    487 ( 163 )
        Cycle 3 Day 1
    614 ( 209 )
    No statistical analyses for this end point

    Secondary: Minimum Serum Concentration (Cmin) of Atezolizumab

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    End point title
    		 Minimum Serum Concentration (Cmin) of Atezolizumab [259]
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
    Notes
    [259] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis for this endpoint.
    End point values
    		 Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    532
    Units: µg/mL
    arithmetic mean (standard deviation)
        Cycle 2 Day 1
    88.9 ( 35.8 )
        Cycle 3 Day 1
    146 ( 93.0 )
        Cycle 4 Day 1
    149 ( 88.1 )
        Cycle 8 Day 1
    242 ( 96.3 )
        Cycle 16 Day 1
    286 ( 111 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

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    End point title
    		 Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [260]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to approximately 55 months
    Notes
    [260] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis for this endpoint.
    End point values
    		 Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Number of subjects analysed
    569
    Units: Percentage of participants
    number (not applicable)
        Baseline evaluable participants
    0.7
        Post-baseline evaluable participants
    22.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
    Adverse event reporting additional description
    Adverse events reported based on safety population, which included participants who received any amount of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    Reporting 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.

    Reporting group title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Reporting 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.

    Serious adverse events
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    215 / 644 (33.39%)
    304 / 642 (47.35%)
         number of deaths (all causes)
    301
    280
         number of deaths resulting from adverse events
    4
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PAPILLARY THYROID CANCER
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INVASIVE DUCTAL BREAST CARCINOMA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL STROMAL TUMOUR
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAPLASTIC ASTROCYTOMA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    AORTIC DISSECTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CIRCULATORY COLLAPSE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    2 / 644 (0.31%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMBOLISM
         subjects affected / exposed
    3 / 644 (0.47%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMBOLISM VENOUS
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    4 / 644 (0.62%)
    5 / 642 (0.78%)
         occurrences causally related to treatment / all
    2 / 4
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSIVE URGENCY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTENSION
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHOCELE
         subjects affected / exposed
    2 / 644 (0.31%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHORRHOEA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SHOCK HAEMORRHAGIC
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONDITION AGGRAVATED
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEATH
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    DEVICE RELATED THROMBOSIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EARLY SATIETY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    2 / 644 (0.31%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    0 / 644 (0.00%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE ORGAN DYSFUNCTION SYNDROME
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    2 / 644 (0.31%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    8 / 644 (1.24%)
    26 / 642 (4.05%)
         occurrences causally related to treatment / all
    5 / 9
    17 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    ANAPHYLACTIC SHOCK
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAPHYLACTIC REACTION
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONTRAST MEDIA ALLERGY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    3 / 644 (0.47%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYTOKINE RELEASE SYNDROME
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERSENSITIVITY
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYSTEMIC IMMUNE ACTIVATION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMMUNE-MEDIATED ADVERSE REACTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARCOIDOSIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    FEMALE GENITAL TRACT FISTULA
         subjects affected / exposed
    2 / 644 (0.31%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL FISTULA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEAVY MENSTRUAL BLEEDING
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPIRATION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE RESPIRATORY DISTRESS SYNDROME
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    DYSPNOEA
         subjects affected / exposed
    2 / 644 (0.31%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPISTAXIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERVENTILATION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIA
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT CONGESTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONITIS
         subjects affected / exposed
    2 / 644 (0.31%)
    5 / 642 (0.78%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    6 / 644 (0.93%)
    10 / 642 (1.56%)
         occurrences causally related to treatment / all
    3 / 6
    7 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PULMONARY HAEMORRHAGE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    DELIRIUM
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDAL IDEATION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEPRESSION
         subjects affected / exposed
    2 / 644 (0.31%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    BLOOD POTASSIUM DECREASED
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIPASE INCREASED
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERNATIONAL NORMALISED RATIO INCREASED
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    7 / 644 (1.09%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    7 / 7
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    10 / 644 (1.55%)
    6 / 642 (0.93%)
         occurrences causally related to treatment / all
    10 / 13
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    2 / 644 (0.31%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FASCIAL RUPTURE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    1 / 644 (0.16%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONCUSSION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOT FRACTURE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FRACTURE
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FRACTURED SACRUM
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL ANASTOMOTIC LEAK
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL INJURY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISION SITE IMPAIRED HEALING
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL HERNIA
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFUSION RELATED REACTION
         subjects affected / exposed
    2 / 644 (0.31%)
    5 / 642 (0.78%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPROSTHETIC FRACTURE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL INTESTINAL PERFORATION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL COMPRESSION FRACTURE
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND COMPLICATION
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL CUFF DEHISCENCE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND DEHISCENCE
         subjects affected / exposed
    3 / 644 (0.47%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    STOMA PROLAPSE
         subjects affected / exposed
    2 / 644 (0.31%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ANGINA UNSTABLE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARRHYTHMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL TACHYCARDIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL THROMBOSIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ARREST
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOMYOPATHY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOVASCULAR DISORDER
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL ISCHAEMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PALPITATIONS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    APHASIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    3 / 644 (0.47%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 3
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    CEREBRAL INFARCTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBELLAR INFARCTION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATAXIA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COGNITIVE DISORDER
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEPRESSED LEVEL OF CONSCIOUSNESS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEMENTIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALOPATHY
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEADACHE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE INTRACRANIAL
         subjects affected / exposed
    1 / 644 (0.16%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    ISCHAEMIC STROKE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYASTHENIA GRAVIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL MOTOR NEUROPATHY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEIZURE
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    2 / 644 (0.31%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    2 / 644 (0.31%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    10 / 644 (1.55%)
    6 / 642 (0.93%)
         occurrences causally related to treatment / all
    9 / 10
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AGRANULOCYTOSIS
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    24 / 644 (3.73%)
    54 / 642 (8.41%)
         occurrences causally related to treatment / all
    25 / 25
    58 / 59
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRANULOCYTOSIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEUKOPENIA
         subjects affected / exposed
    2 / 644 (0.31%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMMUNE THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    5 / 644 (0.78%)
    5 / 642 (0.78%)
         occurrences causally related to treatment / all
    4 / 5
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCYTOPENIA
         subjects affected / exposed
    2 / 644 (0.31%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    10 / 644 (1.55%)
    8 / 642 (1.25%)
         occurrences causally related to treatment / all
    11 / 12
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOTIC MICROANGIOPATHY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYELOSUPPRESSION
         subjects affected / exposed
    2 / 644 (0.31%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    OTOLITHIASIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VERTIGO
         subjects affected / exposed
    3 / 644 (0.47%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    OCULAR MYASTHENIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OPTIC NEUROPATHY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL VEIN OCCLUSION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ULCERATIVE KERATITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL ADHESIONS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 644 (0.31%)
    9 / 642 (1.40%)
         occurrences causally related to treatment / all
    0 / 2
    3 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL DISTENSION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL HAEMORRHAGE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL FISTULA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS
         subjects affected / exposed
    6 / 644 (0.93%)
    11 / 642 (1.71%)
         occurrences causally related to treatment / all
    5 / 6
    11 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONSTIPATION
         subjects affected / exposed
    5 / 644 (0.78%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    11 / 644 (1.71%)
    9 / 642 (1.40%)
         occurrences causally related to treatment / all
    8 / 13
    7 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA HAEMORRHAGIC
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASCITES
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULUM
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULAR PERFORATION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DUODENAL PERFORATION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPEPSIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTERITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOLITIS
         subjects affected / exposed
    4 / 644 (0.62%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC STENOSIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCUTANEOUS FISTULA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL PERFORATION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GINGIVAL PAIN
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEAL PERFORATION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHOIDAL HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEUS
         subjects affected / exposed
    8 / 644 (1.24%)
    12 / 642 (1.87%)
         occurrences causally related to treatment / all
    3 / 10
    3 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCARCERATED INGUINAL HERNIA
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEUS PARALYTIC
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCARCERATED UMBILICAL HERNIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    7 / 644 (1.09%)
    8 / 642 (1.25%)
         occurrences causally related to treatment / all
    1 / 9
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL PERFORATION
         subjects affected / exposed
    3 / 644 (0.47%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    LARGE INTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINAL OBSTRUCTION
         subjects affected / exposed
    2 / 644 (0.31%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINE PERFORATION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MECHANICAL ILEUS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    5 / 644 (0.78%)
    5 / 642 (0.78%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OBSTRUCTION GASTRIC
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORAL LICHEN PLANUS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATIC FISTULA
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    1 / 644 (0.16%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMATOSIS INTESTINALIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONEAL ADHESIONS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    6 / 644 (0.93%)
    10 / 642 (1.56%)
         occurrences causally related to treatment / all
    1 / 6
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL PERFORATION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBILEUS
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOSIS MESENTERIC VESSEL
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UMBILICAL HERNIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    7 / 644 (1.09%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    7 / 8
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLESTASIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG-INDUCED LIVER INJURY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JAUNDICE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMMUNE-MEDIATED HEPATITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC FUNCTION ABNORMAL
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATOTOXICITY
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER INJURY
         subjects affected / exposed
    1 / 644 (0.16%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JAUNDICE CHOLESTATIC
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC FAILURE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ECZEMA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG ERUPTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERYTHEMA MULTIFORME
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN ULCER
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    0 / 644 (0.00%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RASH
         subjects affected / exposed
    0 / 644 (0.00%)
    7 / 642 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LICHEN PLANUS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URTICARIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOXIC SKIN ERUPTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STEVENS-JOHNSON SYNDROME
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    2 / 644 (0.31%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDRONEPHROSIS
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMMUNE-MEDIATED NEPHRITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHRITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHROPATHY
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROTEINURIA
         subjects affected / exposed
    3 / 644 (0.47%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT OBSTRUCTION
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROGENITAL FISTULA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GLOMERULONEPHRITIS CHRONIC
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    ADDISON'S DISEASE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADRENAL INSUFFICIENCY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERPARATHYROIDISM
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AUTOIMMUNE THYROIDITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTHYROIDISM
         subjects affected / exposed
    1 / 644 (0.16%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SECONDARY ADRENOCORTICAL INSUFFICIENCY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    2 / 644 (0.31%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOSITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOPATHY
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYALGIA
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLANK PAIN
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACK PAIN
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL PAIN
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL ABSCESS
         subjects affected / exposed
    3 / 644 (0.47%)
    5 / 642 (0.78%)
         occurrences causally related to treatment / all
    0 / 3
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL INFECTION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    2 / 644 (0.31%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    2 / 644 (0.31%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS VIRAL
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    2 / 644 (0.31%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE INFECTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE COLITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPSTEIN-BARR VIRUS INFECTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA BACTERAEMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOURNIER'S GANGRENE
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    GASTROENTERITIS CLOSTRIDIAL
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GINGIVITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERPES ZOSTER
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED LYMPHOCELE
         subjects affected / exposed
    1 / 644 (0.16%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    1 / 644 (0.16%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHANGITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    KIDNEY INFECTION
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTIOUS MONONUCLEOSIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PELVIC ABSCESS
         subjects affected / exposed
    1 / 644 (0.16%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGOENCEPHALITIS HERPETIC
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PELVIC INFECTION
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGITIS BACTERIAL
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    PERITONSILLITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    7 / 644 (1.09%)
    10 / 642 (1.56%)
         occurrences causally related to treatment / all
    4 / 7
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA VIRAL
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE ABSCESS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULPITIS DENTAL
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    3 / 644 (0.47%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS ACUTE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    9 / 644 (1.40%)
    3 / 642 (0.47%)
         occurrences causally related to treatment / all
    3 / 9
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    SKIN INFECTION
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SEPSIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TONSILLITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 644 (0.16%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL CELLULITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL ABSCESS
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    2 / 644 (0.31%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    5 / 644 (0.78%)
    9 / 642 (1.40%)
         occurrences causally related to treatment / all
    0 / 6
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR DEVICE INFECTION
         subjects affected / exposed
    1 / 644 (0.16%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
         subjects affected / exposed
    3 / 644 (0.47%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL SEPSIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
         subjects affected / exposed
    0 / 644 (0.00%)
    6 / 642 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROLYTE IMBALANCE
         subjects affected / exposed
    0 / 644 (0.00%)
    2 / 642 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOD REFUSAL
         subjects affected / exposed
    1 / 644 (0.16%)
    0 / 642 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERCALCAEMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERMAGNESAEMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERGLYCAEMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    3 / 644 (0.47%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TYPE 1 DIABETES MELLITUS
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOMAGNESAEMIA
         subjects affected / exposed
    0 / 644 (0.00%)
    1 / 642 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATRAEMIA
         subjects affected / exposed
    4 / 644 (0.62%)
    4 / 642 (0.62%)
         occurrences causally related to treatment / all
    2 / 5
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo With Paclitaxel, Carboplatin and Bevacizumab Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    637 / 644 (98.91%)
    637 / 642 (99.22%)
    Vascular disorders
    HOT FLUSH
         subjects affected / exposed
    48 / 644 (7.45%)
    35 / 642 (5.45%)
         occurrences all number
    57
    37
    HYPERTENSION
         subjects affected / exposed
    263 / 644 (40.84%)
    225 / 642 (35.05%)
         occurrences all number
    392
    354
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    79 / 644 (12.27%)
    78 / 642 (12.15%)
         occurrences all number
    117
    102
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    26 / 644 (4.04%)
    45 / 642 (7.01%)
         occurrences all number
    36
    49
    MALAISE
         subjects affected / exposed
    33 / 644 (5.12%)
    35 / 642 (5.45%)
         occurrences all number
    42
    59
    FATIGUE
         subjects affected / exposed
    251 / 644 (38.98%)
    241 / 642 (37.54%)
         occurrences all number
    339
    297
    OEDEMA PERIPHERAL
         subjects affected / exposed
    40 / 644 (6.21%)
    40 / 642 (6.23%)
         occurrences all number
    42
    44
    PYREXIA
         subjects affected / exposed
    54 / 644 (8.39%)
    104 / 642 (16.20%)
         occurrences all number
    75
    124
    PAIN
         subjects affected / exposed
    32 / 644 (4.97%)
    33 / 642 (5.14%)
         occurrences all number
    39
    35
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    80 / 644 (12.42%)
    102 / 642 (15.89%)
         occurrences all number
    101
    127
    DYSPHONIA
         subjects affected / exposed
    44 / 644 (6.83%)
    44 / 642 (6.85%)
         occurrences all number
    50
    47
    DYSPNOEA
         subjects affected / exposed
    86 / 644 (13.35%)
    87 / 642 (13.55%)
         occurrences all number
    110
    112
    EPISTAXIS
         subjects affected / exposed
    139 / 644 (21.58%)
    136 / 642 (21.18%)
         occurrences all number
    178
    166
    NASAL CONGESTION
         subjects affected / exposed
    36 / 644 (5.59%)
    32 / 642 (4.98%)
         occurrences all number
    40
    38
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    41 / 644 (6.37%)
    47 / 642 (7.32%)
         occurrences all number
    50
    58
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    49 / 644 (7.61%)
    38 / 642 (5.92%)
         occurrences all number
    58
    43
    DEPRESSION
         subjects affected / exposed
    38 / 644 (5.90%)
    35 / 642 (5.45%)
         occurrences all number
    41
    41
    INSOMNIA
         subjects affected / exposed
    97 / 644 (15.06%)
    89 / 642 (13.86%)
         occurrences all number
    119
    100
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    59 / 644 (9.16%)
    91 / 642 (14.17%)
         occurrences all number
    100
    142
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    56 / 644 (8.70%)
    89 / 642 (13.86%)
         occurrences all number
    93
    149
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    33 / 644 (5.12%)
    40 / 642 (6.23%)
         occurrences all number
    48
    50
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    24 / 644 (3.73%)
    42 / 642 (6.54%)
         occurrences all number
    44
    55
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    168 / 644 (26.09%)
    177 / 642 (27.57%)
         occurrences all number
    610
    567
    WEIGHT INCREASED
         subjects affected / exposed
    44 / 644 (6.83%)
    50 / 642 (7.79%)
         occurrences all number
    46
    51
    WEIGHT DECREASED
         subjects affected / exposed
    68 / 644 (10.56%)
    84 / 642 (13.08%)
         occurrences all number
    72
    91
    PLATELET COUNT DECREASED
         subjects affected / exposed
    142 / 644 (22.05%)
    137 / 642 (21.34%)
         occurrences all number
    329
    267
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    122 / 644 (18.94%)
    143 / 642 (22.27%)
         occurrences all number
    535
    455
    Injury, poisoning and procedural complications
    INFUSION RELATED REACTION
         subjects affected / exposed
    50 / 644 (7.76%)
    78 / 642 (12.15%)
         occurrences all number
    71
    116
    Nervous system disorders
    DYSGEUSIA
         subjects affected / exposed
    50 / 644 (7.76%)
    56 / 642 (8.72%)
         occurrences all number
    52
    66
    DIZZINESS
         subjects affected / exposed
    80 / 644 (12.42%)
    76 / 642 (11.84%)
         occurrences all number
    102
    93
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    166 / 644 (25.78%)
    152 / 642 (23.68%)
         occurrences all number
    196
    175
    HYPOAESTHESIA
         subjects affected / exposed
    59 / 644 (9.16%)
    50 / 642 (7.79%)
         occurrences all number
    78
    63
    HEADACHE
         subjects affected / exposed
    179 / 644 (27.80%)
    149 / 642 (23.21%)
         occurrences all number
    278
    220
    PARAESTHESIA
         subjects affected / exposed
    40 / 644 (6.21%)
    47 / 642 (7.32%)
         occurrences all number
    65
    57
    PERIPHERAL SENSORY NEUROPATHY
         subjects affected / exposed
    163 / 644 (25.31%)
    178 / 642 (27.73%)
         occurrences all number
    186
    201
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    266 / 644 (41.30%)
    284 / 642 (44.24%)
         occurrences all number
    440
    468
    LEUKOPENIA
         subjects affected / exposed
    76 / 644 (11.80%)
    69 / 642 (10.75%)
         occurrences all number
    243
    197
    NEUTROPENIA
         subjects affected / exposed
    197 / 644 (30.59%)
    195 / 642 (30.37%)
         occurrences all number
    507
    477
    THROMBOCYTOPENIA
         subjects affected / exposed
    134 / 644 (20.81%)
    137 / 642 (21.34%)
         occurrences all number
    275
    278
    Eye disorders
    VISION BLURRED
         subjects affected / exposed
    45 / 644 (6.99%)
    31 / 642 (4.83%)
         occurrences all number
    48
    34
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    49 / 644 (7.61%)
    39 / 642 (6.07%)
         occurrences all number
    60
    51
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    66 / 644 (10.25%)
    49 / 642 (7.63%)
         occurrences all number
    98
    56
    ABDOMINAL PAIN
         subjects affected / exposed
    173 / 644 (26.86%)
    182 / 642 (28.35%)
         occurrences all number
    241
    253
    CONSTIPATION
         subjects affected / exposed
    240 / 644 (37.27%)
    226 / 642 (35.20%)
         occurrences all number
    334
    297
    DIARRHOEA
         subjects affected / exposed
    199 / 644 (30.90%)
    223 / 642 (34.74%)
         occurrences all number
    328
    336
    DRY MOUTH
         subjects affected / exposed
    18 / 644 (2.80%)
    34 / 642 (5.30%)
         occurrences all number
    22
    39
    NAUSEA
         subjects affected / exposed
    337 / 644 (52.33%)
    325 / 642 (50.62%)
         occurrences all number
    628
    565
    DYSPEPSIA
         subjects affected / exposed
    53 / 644 (8.23%)
    44 / 642 (6.85%)
         occurrences all number
    61
    54
    STOMATITIS
         subjects affected / exposed
    67 / 644 (10.40%)
    98 / 642 (15.26%)
         occurrences all number
    106
    138
    VOMITING
         subjects affected / exposed
    156 / 644 (24.22%)
    150 / 642 (23.36%)
         occurrences all number
    230
    209
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    33 / 644 (5.12%)
    28 / 642 (4.36%)
         occurrences all number
    39
    29
    Skin and subcutaneous tissue disorders
    ALOPECIA
         subjects affected / exposed
    410 / 644 (63.66%)
    386 / 642 (60.12%)
         occurrences all number
    415
    393
    DRY SKIN
         subjects affected / exposed
    33 / 644 (5.12%)
    35 / 642 (5.45%)
         occurrences all number
    39
    37
    URTICARIA
         subjects affected / exposed
    10 / 644 (1.55%)
    33 / 642 (5.14%)
         occurrences all number
    12
    49
    RASH MACULO-PAPULAR
         subjects affected / exposed
    17 / 644 (2.64%)
    45 / 642 (7.01%)
         occurrences all number
    19
    67
    RASH
         subjects affected / exposed
    99 / 644 (15.37%)
    152 / 642 (23.68%)
         occurrences all number
    119
    205
    PRURITUS
         subjects affected / exposed
    61 / 644 (9.47%)
    87 / 642 (13.55%)
         occurrences all number
    74
    108
    Renal and urinary disorders
    PROTEINURIA
         subjects affected / exposed
    140 / 644 (21.74%)
    137 / 642 (21.34%)
         occurrences all number
    178
    172
    Endocrine disorders
    HYPERTHYROIDISM
         subjects affected / exposed
    23 / 644 (3.57%)
    51 / 642 (7.94%)
         occurrences all number
    26
    56
    HYPOTHYROIDISM
         subjects affected / exposed
    54 / 644 (8.39%)
    118 / 642 (18.38%)
         occurrences all number
    57
    131
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    285 / 644 (44.25%)
    286 / 642 (44.55%)
         occurrences all number
    451
    444
    BACK PAIN
         subjects affected / exposed
    90 / 644 (13.98%)
    88 / 642 (13.71%)
         occurrences all number
    115
    97
    BONE PAIN
         subjects affected / exposed
    51 / 644 (7.92%)
    45 / 642 (7.01%)
         occurrences all number
    92
    70
    MYALGIA
         subjects affected / exposed
    163 / 644 (25.31%)
    144 / 642 (22.43%)
         occurrences all number
    239
    205
    MUSCULAR WEAKNESS
         subjects affected / exposed
    44 / 644 (6.83%)
    45 / 642 (7.01%)
         occurrences all number
    57
    50
    NECK PAIN
         subjects affected / exposed
    32 / 644 (4.97%)
    34 / 642 (5.30%)
         occurrences all number
    35
    34
    PAIN IN EXTREMITY
         subjects affected / exposed
    89 / 644 (13.82%)
    81 / 642 (12.62%)
         occurrences all number
    121
    110
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    41 / 644 (6.37%)
    41 / 642 (6.39%)
         occurrences all number
    59
    60
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    55 / 644 (8.54%)
    63 / 642 (9.81%)
         occurrences all number
    71
    83
    URINARY TRACT INFECTION
         subjects affected / exposed
    104 / 644 (16.15%)
    109 / 642 (16.98%)
         occurrences all number
    140
    169
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    120 / 644 (18.63%)
    119 / 642 (18.54%)
         occurrences all number
    154
    160
    HYPERGLYCAEMIA
         subjects affected / exposed
    52 / 644 (8.07%)
    46 / 642 (7.17%)
         occurrences all number
    85
    69
    HYPOKALAEMIA
         subjects affected / exposed
    60 / 644 (9.32%)
    72 / 642 (11.21%)
         occurrences all number
    94
    97
    HYPOMAGNESAEMIA
         subjects affected / exposed
    83 / 644 (12.89%)
    92 / 642 (14.33%)
         occurrences all number
    112
    134
    HYPONATRAEMIA
         subjects affected / exposed
    45 / 644 (6.99%)
    48 / 642 (7.48%)
         occurrences all number
    61
    63

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2017
    Protocol was amended to include clarification on the timing from randomization to primary surgery to allow a more feasible retrieval timeframe for the pathology tissue blocks. Following review of newly available PK and ADA data for bevacizumab when administered in combination with atezolizumab, it was decided that no additional assessments were required. Therefore, the bevacizumab PK and ADA assessments were removed.
    06 Oct 2017
    Protocol was amended to clarify that head and neck imaging was mandated only if clinically indicated. Clarification of the guidance surrounding bevacizumab and proteinuria to allow for urine protein/creatinine ratio and when bevacizumab may be started in relation to major surgery. Clarification that screening tumor assessment by CT scan was to be performed within 28 days prior to randomization for both primary surgery participants and neoadjuvant participants.
    22 May 2018
    Protocol was amended to include consistent windows around tumor response evaluations. Clarification of tumor tissue requirements for participants undergoing neoadjuvant treatment. Clarification of the PRO questionnaire distribution and completion. The reporting period for SAEs and AESIs were clarified. Instructions onthe reporting of accidental overdose or medication error administered by the site or not administered by the site were added to strengthen safety monitoring for special situations that may or may not result in an AE. Instructions onthe reporting of accidental overdose or medication error administered by the site or not administered by the site were added to strengthen safety monitoring for special situations that may or may not result in an AE.
    03 Nov 2018
    Protocol was amended to include risks for atezolizumab and guidelines for managing patients who experience atezolizumab-associated AEs were revised to include nephritis. Modification of exclusion criteria to include venous thromboembolism, to specify Grade >=2 hemoptysis, and to clarify current or recent usage of associated medications. Clarification of dosing for bevacizumab to allow sites to obtain and account for the participant’s current weight according to their clinical practice. Clarifications for carboplatin and paclitaxel dose reductions to reinforce allowance of institutional practice. HIPEC was added as a prohibited therapy because it is an anti-cancer chemotherapy.
    29 Jan 2020
    Protocol was amended to include myositis as a risk for atezolizumab. Language was added to clarify that anti-cancer therapy was not permitted after Cycle 22.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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