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This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + Paclitaxel + Carboplatin | Experimental | Participants will receive paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion will start at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first. |
|
| Placebo + Paclitaxel + Carboplatin | Placebo Comparator | Participants will receive paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion will start at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 175 mg/m^2 IV infusion on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. | Randomization up to to death from any cause (up to approximately 54.1 months) |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital, Capital Medical University | Beijing | 100006 | China | |||
| the First Hospital of Jilin University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38872480 | Derived | Wu X, Liu J, An R, Yin R, Zhang Y, Zhou H, He A, Wang L, Zhang J, Liu Z, Duan W, Zhu J, Lou G, Chen G, Cheng Y, Xue F, Nick S, Wang H, Li D. First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e99. doi: 10.3802/jgo.2024.35.e99. Epub 2024 Apr 22. | |
| 37185961 |
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Participants were randomized with a 1:1 allocation ratio to receive Bevacizumab(B) + Paclitaxel (P) + Carboplatin (C) or Placebo + Paclitaxel + Carboplatin.
This study was conducted at 16 centers in mainland China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Paclitaxel + Carboplatin | Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2019 | May 26, 2022 |
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| Bevacizumab | Drug | 15 mg/kg IV infusion on Day 1 of each 21-day cycle. |
|
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| Carboplatin | Drug | Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle. |
|
| Placebo | Drug | Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle. |
|
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.
| Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) |
| Duration of Response (DOR) | 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. | 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) |
| Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical) | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role) | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social) | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional) | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL) | 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). | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
| Percentage of Participants With Adverse Events (AEs) | 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) |
| Changchun |
| 130021 |
| China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Xiangya Hospital Central South University | Changsha | 410008 | China |
| West China Second University Hospital | Chengdu | 610066 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510663 | China |
| Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | 210008 | China |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | 530021 | China |
| Nantong Tumor Hospital | Nantong | 226361 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Derived |
| Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
| FG001 |
| Bevacizumab + Paclitaxel + Carboplatin |
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Paclitaxel + Carboplatin | Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first. |
| BG001 | Bevacizumab + Paclitaxel + Carboplatin | Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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) | 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. | 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. | Posted | Median | 95% Confidence Interval | months | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. | 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. | Posted | Median | 95% Confidence Interval | months | Randomization up to to death from any cause (up to approximately 54.1 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) |
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| Secondary | Duration of Response (DOR) | 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. | 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. | Posted | Median | 80% Confidence Interval | months | 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) |
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| Secondary | Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Bloating | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Physical) | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Role) | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Social) | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Percentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Function (Emotional) | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Pecentage of Participants Who Report a Clinically Meaningful Improvement in Patient-Reported Health Related Quality of Life (HRQoL) | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | 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). | Posted | Number | percentage of participants | 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) |
|
All-cause mortality: From randomization up to end of follow up (54.1 months) AEs and SAEs: 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)
Safety population: participants who received any amount of study treatment (Bev,C or P). Participants were allocated to treatment arms per actual treatment received. 1 participant in Bev+P+C arm withdrew before receiving treatment & was excluded from safety population. 2 participants in Bev+P+C arm did not receive Bev, & were included in Placebo+P+C arm in safety population. 1 participant in Placebo+P+C arm received partial bevacizumab dose & was included in B+P+C arm in safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Paclitaxel + Carboplatin | Participants received paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Placebo IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first. | 19 | 50 | 16 | 50 | 49 | 50 |
| EG001 | Bevacizumab + Paclitaxel + Carboplatin | Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first. | 13 | 49 | 17 | 49 | 49 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Granulocyte count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2020 | May 26, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| <.0001 |
| Hazard Ratio (HR) |
| 0.34 |
| 2-Sided |
| 95 |
| 0.20 |
| 0.58 |
| Superiority |
Unstratified Analysis |
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|
|
|
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|
Participants received paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles. Bevacizumab IV infusion started at Cycle 2 for 5 cycles, followed by maintenance therapy up to a maximum of 22 cycles or until disease progression, unacceptable toxicity, or withdrawal, whichever occurred first.
|
|
|
|