A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

PFS was defined as time from randomization to the first occurrence of disease progression, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.

Time frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment.

DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression,as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurred first. DOR was evaluated for participants who had a objective response of CR or PR.

Time frame: From the date of first occurrence of a complete or partial response until disease progression or death from any cause (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had an objective response (CR or PR) by the investigator per RECIST v1.1 were included in the analysis.

ORR was defined as the proportion of participants with complete response (CR) or partial response (PR) as assessed by investigator according to RECIST v.1.1.

Time frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment.

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame: Randomization up to to death from any cause (up to approximately 54.1 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment.

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

A clinically meaningful improvement in patient-reported function and HRQoL was defined as a \>10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

Time frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months)

Population: The intent-to-treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received. Here, all randomized participants who had a baseline and ≥1 post-baseline PRO assessment were included in the analysis.

Time frame: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks)

Population: The safety population was defined as participants who received any amount of any component of the study treatments (bevacizumab, paclitaxel or carboplatin). Participants were allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to placebo + chemotherapy alone who received at least one full or partial dose of bevacizumab were included in the bevacizumab + chemotherapy arm for safety).