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A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01239732
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Paclitaxel
Drug: Bevacizumab
Drug: Carboplatin
Enrollment 1021

Recruitment Details  
Pre-assignment Details This study has been completed. However, the efficacy and safety results up to the clinical database cutoff date of 07 December 2014 are provided.
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Period Title: Overall Study
Started 1021
Completed 0
Not Completed 1021
Reason Not Completed
Termination of study per protocol             667
Death             226
Withdrawal by Subject             87
Adverse Event             6
Protocol Violation             3
Participant non compliance             5
Study termination by sponsor             2
Investigator's decision             4
Treatment failure             2
Other             19
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Baseline Participants 1021
Hide Baseline Analysis Population Description
Safety population: included all participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1021 participants
56.3  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1021 participants
Female
1021
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 1021
Measure Type: Number
Unit of Measure: percentage of participants
97.8
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.
Time Frame Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population included all participants who received at least one dose of study medication.
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 1021
Median (95% Confidence Interval)
Unit of Measure: months
25.5
(23.7 to 27.6)
3.Secondary Outcome
Title Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
Hide Description Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.
Time Frame Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 421
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.7
(68.2 to 76.9)
4.Secondary Outcome
Title Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
Hide Description CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).
Time Frame 3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 340
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.8
(88.3 to 94.5)
5.Secondary Outcome
Title Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
Hide Description Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.
Time Frame RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 578
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.4
(79.0 to 85.4)
6.Secondary Outcome
Title Duration of Objective Response (DOR)
Hide Description DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).
Time Frame Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 1021
Median (95% Confidence Interval)
Unit of Measure: months
18.2
(16.6 to 19.6)
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.
Time Frame First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 1021
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
The median and 95% confidence interval were not calculable because less than 50% of participants had the event.
8.Secondary Outcome
Title Biological Progression-free Interval
Hide Description Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).
Time Frame 3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee.
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab + Paclitaxel + Carboplatin
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
All-Cause Mortality
Bevacizumab + Paclitaxel + Carboplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Paclitaxel + Carboplatin
Affected / at Risk (%)
Total   285/1021 (27.91%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  25/1021 (2.45%) 
Neutropenia * 1  21/1021 (2.06%) 
Anaemia * 1  16/1021 (1.57%) 
Thrombocytopenia * 1  13/1021 (1.27%) 
Leukopenia * 1  2/1021 (0.20%) 
Thrombotic microangiopathy * 1  2/1021 (0.20%) 
Disseminated intravascular coagulation * 1  1/1021 (0.10%) 
Pancytopenia * 1  1/1021 (0.10%) 
Cardiac disorders   
Acute myocardial infarction * 1  3/1021 (0.29%) 
Cardiac failure congestive * 1  2/1021 (0.20%) 
Myocardial infarction * 1  2/1021 (0.20%) 
Angina pectoris * 1  1/1021 (0.10%) 
Atrial fibrillation * 1  1/1021 (0.10%) 
Coronary artery disease * 1  1/1021 (0.10%) 
Tachycardia * 1  1/1021 (0.10%) 
Gastrointestinal disorders   
Diarrhoea * 1  13/1021 (1.27%) 
Intestinal obstruction * 1  11/1021 (1.08%) 
Ileus * 1  9/1021 (0.88%) 
Subileus * 1  9/1021 (0.88%) 
Abdominal pain * 1  8/1021 (0.78%) 
Small intestinal obstruction * 1  8/1021 (0.78%) 
Constipation * 1  6/1021 (0.59%) 
Vomiting * 1  5/1021 (0.49%) 
Nausea * 1  4/1021 (0.39%) 
Gastrointestinal perforation * 1  3/1021 (0.29%) 
Ascites * 1  2/1021 (0.20%) 
Rectal haemorrhage * 1  2/1021 (0.20%) 
Umbilical hernia * 1  2/1021 (0.20%) 
Abdominal hernia * 1  1/1021 (0.10%) 
Abdominal incarcerated hernia * 1  1/1021 (0.10%) 
Abdominal pain upper * 1  1/1021 (0.10%) 
Anal fistula * 1  1/1021 (0.10%) 
Dysphagia * 1  1/1021 (0.10%) 
Enterocolitis haemorrhagic * 1  1/1021 (0.10%) 
Faecaloma * 1  1/1021 (0.10%) 
Gastric stenosis * 1  1/1021 (0.10%) 
Gastric ulcer * 1  1/1021 (0.10%) 
Gastrointestinal haemorrhage * 1  1/1021 (0.10%) 
Gastrointestinal inflammation * 1  1/1021 (0.10%) 
Gastrointestinal toxicity * 1  1/1021 (0.10%) 
Haemorrhoids * 1  1/1021 (0.10%) 
Haemorrhoids thrombosed * 1  1/1021 (0.10%) 
Intestinal perforation * 1  1/1021 (0.10%) 
Jejunal perforation * 1  1/1021 (0.10%) 
Large intestinal obstruction * 1  1/1021 (0.10%) 
Large intestine perforation * 1  1/1021 (0.10%) 
Lower gastrointestinal haemorrhage * 1  1/1021 (0.10%) 
Mallory-weiss syndrome * 1  1/1021 (0.10%) 
Mechanical ileus * 1  1/1021 (0.10%) 
Mouth haemorrhage * 1  1/1021 (0.10%) 
Oesophagitis * 1  1/1021 (0.10%) 
Pancreatitis * 1  1/1021 (0.10%) 
General disorders   
Pyrexia * 1  6/1021 (0.59%) 
General physical health deterioration * 1  4/1021 (0.39%) 
Asthenia * 1  3/1021 (0.29%) 
Chest pain * 1  2/1021 (0.20%) 
Impaired healing * 1  2/1021 (0.20%) 
Death * 1  1/1021 (0.10%) 
Fatigue * 1  1/1021 (0.10%) 
Mucosal inflammation * 1  1/1021 (0.10%) 
Oedema peripheral * 1  1/1021 (0.10%) 
Performance status decreased * 1  1/1021 (0.10%) 
Hepatobiliary disorders   
Cholecystitis acute * 1  1/1021 (0.10%) 
Jaundice cholestatic * 1  1/1021 (0.10%) 
Immune system disorders   
Drug hypersensitivity * 1  1/1021 (0.10%) 
Infections and infestations   
Pneumonia * 1  5/1021 (0.49%) 
Urinary tract infection * 1  5/1021 (0.49%) 
Infected lymphocele * 1  4/1021 (0.39%) 
Infection * 1  3/1021 (0.29%) 
Cellulitis * 1  3/1021 (0.29%) 
Gastroenteritis * 1  3/1021 (0.29%) 
Nasopharyngitis * 1  2/1021 (0.20%) 
Abdominal wall abscess * 1  2/1021 (0.20%) 
Anal abscess * 1  2/1021 (0.20%) 
Device related infection * 1  2/1021 (0.20%) 
Influenza * 1  2/1021 (0.20%) 
Lung infection * 1  2/1021 (0.20%) 
Pelvic abscess * 1  2/1021 (0.20%) 
Pharyngitis * 1  2/1021 (0.20%) 
Sepsis * 1  2/1021 (0.20%) 
Upper respiratory tract infection * 1  2/1021 (0.20%) 
Abdominal infection * 1  1/1021 (0.10%) 
Abdominal sepsis * 1  1/1021 (0.10%) 
Acute hepatitis C * 1  1/1021 (0.10%) 
Arthritis infective * 1  1/1021 (0.10%) 
Bronchitis * 1  1/1021 (0.10%) 
Catheter site infection * 1  1/1021 (0.10%) 
Cholecystitis inefective * 1  1/1021 (0.10%) 
Clostridium difficile infection * 1  1/1021 (0.10%) 
Colonic abscess * 1  1/1021 (0.10%) 
Cystitis * 1  1/1021 (0.10%) 
Enterocolitis infectious * 1  1/1021 (0.10%) 
Gastroenteritis viral * 1  1/1021 (0.10%) 
Gingivitis * 1  1/1021 (0.10%) 
Groin abscess * 1  1/1021 (0.10%) 
Infected cyst * 1  1/1021 (0.10%) 
Parotid abscess * 1  1/1021 (0.10%) 
Peritoneal abscess * 1  1/1021 (0.10%) 
Peritonitis * 1  1/1021 (0.10%) 
Postoperative wound infection * 1  1/1021 (0.10%) 
Proctitis infectious * 1  1/1021 (0.10%) 
Septic shock * 1  1/1021 (0.10%) 
Staphylococcal infection * 1  1/1021 (0.10%) 
Subdiaphragmatic abscess * 1  1/1021 (0.10%) 
Urosepsis * 1  1/1021 (0.10%) 
Vulval cellulitis * 1  1/1021 (0.10%) 
Injury, poisoning and procedural complications   
Hand fracture * 1  1/1021 (0.10%) 
Hip fracture * 1  1/1021 (0.10%) 
Infusion related reaction * 1  1/1021 (0.10%) 
Joint dislocation * 1  1/1021 (0.10%) 
Lower limb fracture * 1  1/1021 (0.10%) 
Procedural pain * 1  1/1021 (0.10%) 
Pubis fracture * 1  1/1021 (0.10%) 
Radius fracture * 1  1/1021 (0.10%) 
Seroma * 1  1/1021 (0.10%) 
Spinal compression fracture * 1  1/1021 (0.10%) 
Subdural haematoma * 1  1/1021 (0.10%) 
Transfusion reaction * 1  1/1021 (0.10%) 
Investigations   
Alanine aminotransferase abnormal * 1  1/1021 (0.10%) 
Alanine aminotransferase increased * 1  1/1021 (0.10%) 
Aspartate aminotransferase abnormal * 1  1/1021 (0.10%) 
Aspartate aminotransferase increased * 1  1/1021 (0.10%) 
Blood alkaline phosphatase abnormal * 1  1/1021 (0.10%) 
General physical condition abnormal * 1  1/1021 (0.10%) 
Weight decreased * 1  1/1021 (0.10%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/1021 (0.20%) 
Hypokalaemia * 1  2/1021 (0.20%) 
Decreased appetite * 1  1/1021 (0.10%) 
Hyperkalaemia * 1  1/1021 (0.10%) 
Hyponatraemia * 1  1/1021 (0.10%) 
Nicotinic acid deficiency * 1  1/1021 (0.10%) 
Musculoskeletal and connective tissue disorders   
Arthropathy * 1  1/1021 (0.10%) 
Back pain * 1  1/1021 (0.10%) 
Neck pain * 1  1/1021 (0.10%) 
Pain in extremity * 1  1/1021 (0.10%) 
Rheumatic disorder * 1  1/1021 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer recurrent * 1  1/1021 (0.10%) 
Chronic lymphocytic leukaemia * 1  1/1021 (0.10%) 
Thyroid cancer recurrent * 1  1/1021 (0.10%) 
Nervous system disorders   
Headache * 1  3/1021 (0.29%) 
Transient ischaemic attack * 1  3/1021 (0.29%) 
Generalised tonic-clonic seizure * 1  2/1021 (0.20%) 
Presyncope * 1  2/1021 (0.20%) 
Cerebral haemorrhage * 1  1/1021 (0.10%) 
Cerebral ischaemia * 1  1/1021 (0.10%) 
Cerebrovascular disorder * 1  1/1021 (0.10%) 
Haemorrhage intracranial * 1  1/1021 (0.10%) 
Lacunar infarction * 1  1/1021 (0.10%) 
Leukoencephalopathy * 1  1/1021 (0.10%) 
Peripheral sensorimotor neuropathy * 1  1/1021 (0.10%) 
Posterior reversible encephalopathy syndrome * 1  1/1021 (0.10%) 
Sciatica * 1  1/1021 (0.10%) 
Syncope * 1  1/1021 (0.10%) 
Psychiatric disorders   
Suicide attempt * 1  2/1021 (0.20%) 
Bruxism * 1  1/1021 (0.10%) 
Major depression * 1  1/1021 (0.10%) 
Renal and urinary disorders   
Proteinuria * 1  2/1021 (0.20%) 
Renal failure * 1  2/1021 (0.20%) 
Calculus ureteric * 1  1/1021 (0.10%) 
Glomerulonephritis * 1  1/1021 (0.10%) 
Hydronephrosis * 1  1/1021 (0.10%) 
Nephrotic syndrome * 1  1/1021 (0.10%) 
Renal infarct * 1  1/1021 (0.10%) 
Tubulointerstitial nephritis * 1  1/1021 (0.10%) 
Ureteric obstruction * 1  1/1021 (0.10%) 
Reproductive system and breast disorders   
Female genital tract fistula * 1  2/1021 (0.20%) 
Pelvic pain * 1  1/1021 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  8/1021 (0.78%) 
Pneumothorax * 1  2/1021 (0.20%) 
Dyspnoea * 1  1/1021 (0.10%) 
Haemoptysis * 1  1/1021 (0.10%) 
Pleural effusion * 1  1/1021 (0.10%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  3/1021 (0.29%) 
Erythema * 1  1/1021 (0.10%) 
Paraneoplastic dermatomyositis * 1  1/1021 (0.10%) 
Psoriasis * 1  1/1021 (0.10%) 
Surgical and medical procedures   
Intestinal operation * 1  1/1021 (0.10%) 
Vascular disorders   
Hypertension * 1  16/1021 (1.57%) 
Embolism venous * 1  9/1021 (0.88%) 
Lymphocele * 1  8/1021 (0.78%) 
Deep vein thrombosis * 1  2/1021 (0.20%) 
Embolism arterial * 1  2/1021 (0.20%) 
Lymphoedema * 1  2/1021 (0.20%) 
Arterial thrombosis * 1  1/1021 (0.10%) 
Hypovolaemic shock * 1  1/1021 (0.10%) 
Malignant hypertension * 1  1/1021 (0.10%) 
Orthostatic hypotension * 1  1/1021 (0.10%) 
Thrombophlebitis * 1  1/1021 (0.10%) 
Venous thrombosis limb * 1  1/1021 (0.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab + Paclitaxel + Carboplatin
Affected / at Risk (%)
Total   980/1021 (95.98%) 
Blood and lymphatic system disorders   
Neutropenia * 1  485/1021 (47.50%) 
Anaemia * 1  333/1021 (32.62%) 
Thrombocytopenia * 1  279/1021 (27.33%) 
Leukopenia * 1  109/1021 (10.68%) 
Gastrointestinal disorders   
Nausea * 1  393/1021 (38.49%) 
Diarrhoea * 1  258/1021 (25.27%) 
Constipation * 1  255/1021 (24.98%) 
Vomiting * 1  230/1021 (22.53%) 
Abdominal pain * 1  221/1021 (21.65%) 
Stomatitis * 1  110/1021 (10.77%) 
Abdominal pain upper * 1  104/1021 (10.19%) 
Gingival bleeding * 1  75/1021 (7.35%) 
General disorders   
Fatigue * 1  372/1021 (36.43%) 
Asthenia * 1  135/1021 (13.22%) 
Mucosal inflammation * 1  110/1021 (10.77%) 
Pyrexia * 1  86/1021 (8.42%) 
Oedema peripheral * 1  63/1021 (6.17%) 
Infections and infestations   
Urinary tract infection * 1  122/1021 (11.95%) 
Nasopharyngitis * 1  83/1021 (8.13%) 
Upper respiratory tract infection * 1  60/1021 (5.88%) 
Investigations   
Platelet count decreased * 1  93/1021 (9.11%) 
Weight increased * 1  77/1021 (7.54%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  94/1021 (9.21%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  261/1021 (25.56%) 
Myalgia * 1  185/1021 (18.12%) 
Pain in extremity * 1  138/1021 (13.52%) 
Back pain * 1  133/1021 (13.03%) 
Musculoskeletal pain * 1  132/1021 (12.93%) 
Bone pain * 1  52/1021 (5.09%) 
Nervous system disorders   
Headache * 1  241/1021 (23.60%) 
Neuropathy peripheral * 1  201/1021 (19.69%) 
Peripheral sensory neuropathy * 1  161/1021 (15.77%) 
Paraesthesia * 1  134/1021 (13.12%) 
Dizziness * 1  75/1021 (7.35%) 
Dysgeusia * 1  68/1021 (6.66%) 
Psychiatric disorders   
Insomnia * 1  66/1021 (6.46%) 
Renal and urinary disorders   
Proteinuria * 1  317/1021 (31.05%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  301/1021 (29.48%) 
Cough * 1  94/1021 (9.21%) 
Dyspnoea * 1  66/1021 (6.46%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  442/1021 (43.29%) 
Rash * 1  76/1021 (7.44%) 
Pruritus * 1  71/1021 (6.95%) 
Vascular disorders   
Hypertension * 1  552/1021 (54.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01239732     History of Changes
Other Study ID Numbers: MO22923
2010-019525-34 ( EudraCT Number )
First Submitted: November 10, 2010
First Posted: November 11, 2010
Results First Submitted: March 17, 2016
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016