A Study of Atezolizumab Versus Placebo in Combination Wit... | NCT03038100

ID	Type	Description	Link
2016-003472-52	EudraCT Number

Name	Class
GOG Foundation	NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)	OTHER

Label	Type	Description	Intervention Names
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Experimental	Participants in the primary tumor-reductive surgery group will receive 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 will receive 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 will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.	Drug: Paclitaxel Drug: Carboplatin Drug: Atezolizumab Drug: Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab	Placebo Comparator	Participants in the primary tumor-reductive surgery group will receive 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 will receive 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 will start maintenance therapy of bevacizumab and placebo for additional 16 cycles.	Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab Drug: Atezolizumab Placebo

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel	Drug	Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Measure	Description	Time Frame
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	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.	From randomization until disease progression or death from any cause (up to approximately 55 months)
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation	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.	From randomization until disease progression or death from any cause (up to approximately 55 months)
Overall Survival - ITT Population	Overall Survival (OS) is defined as the time from randomization to death from any cause.	From randomization up to death from any cause (up to approximately 59 months)
Overall Survival - PD-L1-Positive Subpopulation	Overall Survival (OS) is defined as the time from randomization to death from any cause.	From randomization up to death from any cause (up to approximately 59 months)

Measure	Description	Time Frame
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population	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.	From randomization until disease progression or death from any cause (up to approximately 55 months)

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph'S Hospital & Medical Center		Phoenix	Arizona	85013	United States
Arizona Oncology Associates, PC - HAL

PubMed Identifier	Type	Citation	Retractions
37625235	Derived	Pignata S, Bookman M, Sehouli J, Miller A, Penson RT, Taskiran C, Anderson C, Hietanen S, Myers T, Madry R, Willmott L, Lortholary A, Thomes-Pepin J, Aghajanian C, McCourt C, Stuckey A, Wu X, Nishio S, Copeland LJ, He Y, Molinero L, Patel S, Lin YG, Khor VK, Moore KN. Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer. Gynecol Oncol. 2023 Oct;177:20-31. doi: 10.1016/j.ygyno.2023.06.018. Epub 2023 Aug 23.
36595569

ID	Title	Description
FG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 22, 2021	Jan 9, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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.

Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From randomization until disease progression or death from any cause (up to approximately 55 months)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Units	Counts
Participants	OG000650 OG001651

Title

Denominators

Categories

Title	Measurements
	OG00018.37(17.22 to 19.75) OG00119.48(18.14 to 20.76)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.2785		Hazard Ratio (HR)	0.92			2-Sided	95	0.79	1.07					Superiority

Primary

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

PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.

Posted

Median

95% Confidence Interval

Months

From randomization until disease progression or death from any cause (up to approximately 55 months)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Primary

Overall Survival - ITT Population

Overall Survival (OS) is defined as the time from randomization to death from any cause.

Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

From randomization up to death from any cause (up to approximately 59 months)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Primary

Overall Survival - PD-L1-Positive Subpopulation

Overall Survival (OS) is defined as the time from randomization to death from any cause.

PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.

Posted

Median

95% Confidence Interval

Months

From randomization up to death from any cause (up to approximately 59 months)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Secondary

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

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.

Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.

Posted

Number

Percentage of participants

From randomization until disease progression or death from any cause (up to approximately 55 months)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

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

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.

Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.

Posted

Number

Percentage of participants

From randomization until disease progression or death from any cause (up to approximately 55 months)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Secondary

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

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.

Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

Posted

Median

95% Confidence Interval

Months

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)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.

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

Duration of Objective Response (DOR) - evaluable population is defined as patients with an objective response. The PD-L1-positive subpopulation (defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization) who underwent primary tumor-reductive surgery.

Posted

Median

95% Confidence Interval

Months

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)

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.

Secondary

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

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).

Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

Posted

Number

Percentage of participants

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.

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.

Secondary

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

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).

PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.

Posted

Number

Percentage of participants

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.

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.

Secondary

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

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.

PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.

Posted

Number

Percentage of participants

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.

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Secondary

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

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.

PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.

Posted

Number

Percentage of participants

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.

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Secondary

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

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.

PRO-evaluable population is defined as patients in the ITT population with a baseline and >=1 post-baseline PRO assessment.

Posted

Number

Percentage of participants

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.

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Secondary

Percentage of Participants With at Least One Adverse Event

Percentage of participants with at least one adverse event.

Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).

Posted

Number

Percentage

From randomization up to approximately 59 months

ID	Title	Description
OG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
OG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Secondary

Maximum Serum Concentration (Cmax) of Atezolizumab

PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.

Posted

Mean

Standard Deviation

µg/mL

Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose

ID	Title	Description
OG000	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Units	Counts
Participants	OG000

Secondary

Minimum Serum Concentration (Cmin) of Atezolizumab

PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.

Posted

Mean

Standard Deviation

µg/mL

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

ID	Title	Description
OG000	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Units	Counts
Participants	OG000

Secondary

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

PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.

Posted

Number

Percentage of participants

Baseline to approximately 55 months

ID	Title	Description
OG000	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
AGRANULOCYTOSIS	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0007 events6 affected642 at risk EG00110 events10 affected644 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG00059 events54 affected642 at risk EG00125 events24 affected644 at risk
GRANULOCYTOSIS	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
IMMUNE THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0012 events2 affected644 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0005 events5 affected642 at risk EG0015 events5 affected644 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0012 events2 affected644 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG00011 events8 affected642 at risk EG00112 events10 affected644 at risk
THROMBOTIC MICROANGIOPATHY	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
CARDIOVASCULAR DISORDER	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MYOCARDITIS	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
PALPITATIONS	Cardiac disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
OTOLITHIASIS	Ear and labyrinth disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0013 events3 affected644 at risk
ADDISON'S DISEASE	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
AUTOIMMUNE THYROIDITIS	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPERPARATHYROIDISM	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0011 events1 affected644 at risk
SECONDARY ADRENOCORTICAL INSUFFICIENCY	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
OCULAR MYASTHENIA	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
OPTIC NEUROPATHY	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ULCERATIVE KERATITIS	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ABDOMINAL ADHESIONS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0009 events9 affected642 at risk EG0012 events2 affected644 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
ANAL FISTULA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ANAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events1 affected642 at risk EG0010 events0 affected644 at risk
ASCITES	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
COLITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00012 events11 affected642 at risk EG0016 events6 affected644 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0015 events5 affected644 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00011 events9 affected642 at risk EG00113 events11 affected644 at risk
DIARRHOEA HAEMORRHAGIC	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
DIVERTICULAR PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
DUODENAL PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0014 events4 affected644 at risk
ENTEROCUTANEOUS FISTULA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
GASTRIC STENOSIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events1 affected642 at risk EG0010 events0 affected644 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
GASTROINTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ILEAL PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ILEUS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00014 events12 affected642 at risk EG00110 events8 affected644 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
INCARCERATED INGUINAL HERNIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
INCARCERATED UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0008 events8 affected642 at risk EG0019 events7 affected644 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0013 events3 affected644 at risk
LARGE INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
LARGE INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0012 events2 affected644 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0011 events1 affected644 at risk
MECHANICAL ILEUS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
NAUSEA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0005 events5 affected642 at risk EG0015 events5 affected644 at risk
OBSTRUCTION GASTRIC	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ORAL LICHEN PLANUS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PANCREATIC FISTULA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PERITONEAL ADHESIONS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PNEUMATOSIS INTESTINALIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0011 events1 affected644 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00011 events10 affected642 at risk EG0016 events6 affected644 at risk
SMALL INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
THROMBOSIS MESENTERIC VESSEL	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
VOMITING	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG0005 events4 affected642 at risk EG0018 events7 affected644 at risk
ASTHENIA	General disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
CONDITION AGGRAVATED	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
DEATH	General disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
DEVICE RELATED THROMBOSIS	General disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
EARLY SATIETY	General disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
FATIGUE	General disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0012 events2 affected644 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events3 affected642 at risk EG0010 events0 affected644 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0012 events2 affected644 at risk
PAIN	General disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PYREXIA	General disorders	MedDRA version 25.0	Systematic Assessment	EG00031 events26 affected642 at risk EG0019 events8 affected644 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
IMMUNE-MEDIATED HEPATITIS	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
JAUNDICE CHOLESTATIC	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
LIVER INJURY	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0011 events1 affected644 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
ANAPHYLACTIC SHOCK	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
CONTRAST MEDIA ALLERGY	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
CYTOKINE RELEASE SYNDROME	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0013 events3 affected644 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
IMMUNE-MEDIATED ADVERSE REACTION	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
SYSTEMIC IMMUNE ACTIVATION	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0005 events5 affected642 at risk EG0013 events3 affected644 at risk
ABDOMINAL INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
APPENDICITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
BACTERAEMIA	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0013 events2 affected644 at risk
BRONCHITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0012 events2 affected644 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
CELLULITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0012 events2 affected644 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
ENCEPHALITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
EPSTEIN-BARR VIRUS INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
FOURNIER'S GANGRENE	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
GASTROENTERITIS CLOSTRIDIAL	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
GINGIVITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HERPES ZOSTER	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
INFECTED LYMPHOCELE	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0011 events1 affected644 at risk
INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0011 events1 affected644 at risk
INFECTIOUS MONONUCLEOSIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
INFLUENZA	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
KIDNEY INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
LYMPHANGITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
MENINGITIS BACTERIAL	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MENINGOENCEPHALITIS HERPETIC	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
PELVIC ABSCESS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0011 events1 affected644 at risk
PELVIC INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
PERITONITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0010 events0 affected644 at risk
PERITONSILLITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
PNEUMONIA	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG00010 events10 affected642 at risk EG0017 events7 affected644 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
POSTOPERATIVE ABSCESS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
PULPITIS DENTAL	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0005 events4 affected642 at risk EG0013 events3 affected644 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
SEPSIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0019 events9 affected644 at risk
SKIN INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
TONSILLITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0011 events1 affected644 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0009 events9 affected642 at risk EG0016 events5 affected644 at risk
UROSEPSIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0012 events2 affected644 at risk
VAGINAL ABSCESS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
VAGINAL CELLULITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
VASCULAR DEVICE INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
WOUND INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0013 events3 affected644 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
FALL	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0011 events1 affected644 at risk
FASCIAL RUPTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
FRACTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
FRACTURED SACRUM	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
GASTROINTESTINAL ANASTOMOTIC LEAK	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
GASTROINTESTINAL INJURY	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
INCISION SITE IMPAIRED HEALING	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0005 events5 affected642 at risk EG0012 events2 affected644 at risk
PERIPROSTHETIC FRACTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
PROCEDURAL INTESTINAL PERFORATION	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
VAGINAL CUFF DEHISCENCE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0013 events2 affected644 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0015 events3 affected644 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
LIPASE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0017 events7 affected644 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0009 events6 affected642 at risk EG00113 events10 affected644 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0013 events2 affected644 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0006 events6 affected642 at risk EG0010 events0 affected644 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
FOOD REFUSAL	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPERMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0013 events3 affected644 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0004 events4 affected642 at risk EG0015 events4 affected644 at risk
TYPE 1 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0012 events2 affected644 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
MYOPATHY	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MYOSITIS	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ANAPLASTIC ASTROCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
GASTROINTESTINAL STROMAL TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
INVASIVE DUCTAL BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PAPILLARY THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
APHASIA	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ATAXIA	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events2 affected642 at risk EG0013 events3 affected644 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DEMENTIA	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
DIZZINESS	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
EPILEPSY	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0011 events1 affected644 at risk
HEADACHE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MYASTHENIA GRAVIS	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PRESYNCOPE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
SEIZURE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events2 affected642 at risk EG0010 events0 affected644 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
SYNCOPE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0012 events2 affected644 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG0005 events4 affected642 at risk EG0012 events2 affected644 at risk
DELIRIUM	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
DEPRESSION	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0013 events2 affected644 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0012 events2 affected644 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
IMMUNE-MEDIATED NEPHRITIS	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
NEPHRITIS	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
NEPHROPATHY	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0013 events3 affected644 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
UROGENITAL FISTULA	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
FEMALE GENITAL TRACT FISTULA	Reproductive system and breast disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0012 events2 affected644 at risk
VAGINAL FISTULA	Reproductive system and breast disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0012 events2 affected644 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
LOWER RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0006 events5 affected642 at risk EG0012 events2 affected644 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG00010 events10 affected642 at risk EG0016 events6 affected644 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
LICHEN PLANUS	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0007 events7 affected642 at risk EG0010 events0 affected644 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0010 events0 affected644 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
STEVENS-JOHNSON SYNDROME	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected644 at risk
TOXIC SKIN ERUPTION	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0002 events2 affected642 at risk EG0012 events2 affected644 at risk
EMBOLISM	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0003 events3 affected642 at risk EG0013 events3 affected644 at risk
EMBOLISM VENOUS	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected644 at risk
HAEMORRHAGE	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPERTENSION	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0005 events5 affected642 at risk EG0014 events4 affected644 at risk
HYPERTENSIVE URGENCY	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
HYPOTENSION	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected644 at risk
LYMPHOCELE	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0012 events2 affected644 at risk
LYMPHORRHOEA	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
MYELOSUPPRESSION	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG0005 events3 affected642 at risk EG0012 events2 affected644 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
SARCOIDOSIS	Immune system disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
DIVERTICULITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
GASTROENTERITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected644 at risk
STOMA PROLAPSE	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG0001 events1 affected642 at risk EG0012 events2 affected644 at risk
GLOMERULONEPHRITIS CHRONIC	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk
HEAVY MENSTRUAL BLEEDING	Reproductive system and breast disorders	MedDRA version 25.0	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected644 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG000468 events284 affected642 at risk EG001440 events266 affected644 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG000197 events69 affected642 at risk EG001243 events76 affected644 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG000477 events195 affected642 at risk EG001507 events197 affected644 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 25.0	Systematic Assessment	EG000278 events137 affected642 at risk EG001275 events134 affected644 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG00056 events51 affected642 at risk EG00126 events23 affected644 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA version 25.0	Systematic Assessment	EG000131 events118 affected642 at risk EG00157 events54 affected644 at risk
VISION BLURRED	Eye disorders	MedDRA version 25.0	Systematic Assessment	EG00034 events31 affected642 at risk EG00148 events45 affected644 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00051 events39 affected642 at risk EG00160 events49 affected644 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG000253 events182 affected642 at risk EG001241 events173 affected644 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00056 events49 affected642 at risk EG00198 events66 affected644 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG000297 events226 affected642 at risk EG001334 events240 affected644 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG000336 events223 affected642 at risk EG001328 events199 affected644 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00039 events34 affected642 at risk EG00122 events18 affected644 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00054 events44 affected642 at risk EG00161 events53 affected644 at risk
NAUSEA	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG000565 events325 affected642 at risk EG001628 events337 affected644 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG000138 events98 affected642 at risk EG001106 events67 affected644 at risk
VOMITING	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG000209 events150 affected642 at risk EG001230 events156 affected644 at risk
ASTHENIA	General disorders	MedDRA version 25.0	Systematic Assessment	EG000102 events78 affected642 at risk EG001117 events79 affected644 at risk
FATIGUE	General disorders	MedDRA version 25.0	Systematic Assessment	EG000297 events241 affected642 at risk EG001339 events251 affected644 at risk
MALAISE	General disorders	MedDRA version 25.0	Systematic Assessment	EG00059 events35 affected642 at risk EG00142 events33 affected644 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA version 25.0	Systematic Assessment	EG00049 events45 affected642 at risk EG00136 events26 affected644 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA version 25.0	Systematic Assessment	EG00044 events40 affected642 at risk EG00142 events40 affected644 at risk
PYREXIA	General disorders	MedDRA version 25.0	Systematic Assessment	EG000124 events104 affected642 at risk EG00175 events54 affected644 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG00060 events41 affected642 at risk EG00159 events41 affected644 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG00083 events63 affected642 at risk EG00171 events55 affected644 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 25.0	Systematic Assessment	EG000169 events109 affected642 at risk EG001140 events104 affected644 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version 25.0	Systematic Assessment	EG000116 events78 affected642 at risk EG00171 events50 affected644 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG000142 events91 affected642 at risk EG001100 events59 affected644 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG000149 events89 affected642 at risk EG00193 events56 affected644 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG00050 events40 affected642 at risk EG00148 events33 affected644 at risk
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG00055 events42 affected642 at risk EG00144 events24 affected644 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG000567 events177 affected642 at risk EG001610 events168 affected644 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG000267 events137 affected642 at risk EG001329 events142 affected644 at risk
WEIGHT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG00091 events84 affected642 at risk EG00172 events68 affected644 at risk
WEIGHT INCREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG00051 events50 affected642 at risk EG00146 events44 affected644 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA version 25.0	Systematic Assessment	EG000455 events143 affected642 at risk EG001535 events122 affected644 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG000160 events119 affected642 at risk EG001154 events120 affected644 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG00069 events46 affected642 at risk EG00185 events52 affected644 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG00097 events72 affected642 at risk EG00194 events60 affected644 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG000134 events92 affected642 at risk EG001112 events83 affected644 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version 25.0	Systematic Assessment	EG00063 events48 affected642 at risk EG00161 events45 affected644 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG000444 events286 affected642 at risk EG001451 events285 affected644 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00097 events88 affected642 at risk EG001115 events90 affected644 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00070 events45 affected642 at risk EG00192 events51 affected644 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00050 events45 affected642 at risk EG00157 events44 affected644 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG000205 events144 affected642 at risk EG001239 events163 affected644 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00034 events34 affected642 at risk EG00135 events32 affected644 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version 25.0	Systematic Assessment	EG000110 events81 affected642 at risk EG001121 events89 affected644 at risk
DIZZINESS	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG00093 events76 affected642 at risk EG001102 events80 affected644 at risk
DYSGEUSIA	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG00066 events56 affected642 at risk EG00152 events50 affected644 at risk
HEADACHE	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG000220 events149 affected642 at risk EG001278 events179 affected644 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG00063 events50 affected642 at risk EG00178 events59 affected644 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG000175 events152 affected642 at risk EG001196 events166 affected644 at risk
PARAESTHESIA	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG00057 events47 affected642 at risk EG00165 events40 affected644 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA version 25.0	Systematic Assessment	EG000201 events178 affected642 at risk EG001186 events163 affected644 at risk
ANXIETY	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG00043 events38 affected642 at risk EG00158 events49 affected644 at risk
DEPRESSION	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG00041 events35 affected642 at risk EG00141 events38 affected644 at risk
INSOMNIA	Psychiatric disorders	MedDRA version 25.0	Systematic Assessment	EG000100 events89 affected642 at risk EG001119 events97 affected644 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA version 25.0	Systematic Assessment	EG000172 events137 affected642 at risk EG001178 events140 affected644 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG000127 events102 affected642 at risk EG001101 events80 affected644 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG00047 events44 affected642 at risk EG00150 events44 affected644 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG000112 events87 affected642 at risk EG001110 events86 affected644 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG000166 events136 affected642 at risk EG001178 events139 affected644 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG00038 events32 affected642 at risk EG00140 events36 affected644 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA version 25.0	Systematic Assessment	EG00058 events47 affected642 at risk EG00150 events41 affected644 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG000393 events386 affected642 at risk EG001415 events410 affected644 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00037 events35 affected642 at risk EG00139 events33 affected644 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG000108 events87 affected642 at risk EG00174 events61 affected644 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG000205 events152 affected642 at risk EG001119 events99 affected644 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00067 events45 affected642 at risk EG00119 events17 affected644 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA version 25.0	Systematic Assessment	EG00049 events33 affected642 at risk EG00112 events10 affected644 at risk
HOT FLUSH	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG00037 events35 affected642 at risk EG00157 events48 affected644 at risk
HYPERTENSION	Vascular disorders	MedDRA version 25.0	Systematic Assessment	EG000354 events225 affected642 at risk EG001392 events263 affected644 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA version 25.0	Systematic Assessment	EG00029 events28 affected642 at risk EG00139 events33 affected644 at risk
PAIN	General disorders	MedDRA version 25.0	Systematic Assessment	EG00035 events33 affected642 at risk EG00139 events32 affected644 at risk

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms
D010534	Peritoneal Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases
D000008	Abdominal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D010532	Peritoneal Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
BG001	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.	272	651	304	642	637	642
EG001	Placebo With Paclitaxel, Carboplatin and Bevacizumab	Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.	289	650	215	644	637	644

ID	Term
D017239	Paclitaxel
D016190	Carboplatin
C000594389	atezolizumab
D000068258	Bevacizumab