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Trial record 36 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

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ClinicalTrials.gov Identifier: NCT01131078
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : December 31, 2014
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Bevacizumab [Avastin]
Drug: Capecitabine
Drug: Irinotecan
Enrollment 306
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal. Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Period Title: Overall Study
Started 101 102 103
Completed 0 1 1
Not Completed 101 101 102
Reason Not Completed
Adverse Event             22             12             17
Progressive Disease             58             77             71
Protocol Violation             1             0             0
Lost to Follow-up             1             1             1
Withdrawal by Subject             2             4             3
Non-compliance             3             0             0
Physician Decision             10             6             8
Death             4             0             2
Other             0             1             0
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2) Total
Hide Arm/Group Description Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal. Total of all reporting groups
Overall Number of Baseline Participants 101 102 103 306
Hide Baseline Analysis Population Description
All enrolled participants were included in the Intent-to-Treat (ITT) population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 102 participants 103 participants 306 participants
61.60  (9.35) 61.46  (10.22) 61.01  (10.10) 61.36  (9.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 102 participants 103 participants 306 participants
Female
58
  57.4%
53
  52.0%
63
  61.2%
174
  56.9%
Male
43
  42.6%
49
  48.0%
40
  38.8%
132
  43.1%
1.Primary Outcome
Title Percentage of Participants With Disease Progression or Death
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population;
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 101 102 103
Measure Type: Number
Unit of Measure: percentage of participants
86.14 90.20 88.35
2.Primary Outcome
Title Time to Progression (TTP)
Hide Description TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; only those participants with an event of disease progression or death were included in the analysis
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 87 92 91
Median (95% Confidence Interval)
Unit of Measure: months
8.35
(7.23 to 9.60)
8.15
(6.74 to 8.75)
7.27
(4.57 to 8.98)
3.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description Overall survival is defined as the time from date of randomization until death from any cause
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 101 102 103
Measure Type: Number
Unit of Measure: percentage of participants
67.33 71.57 73.79
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with an event (death) were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 68 73 76
Median (95% Confidence Interval)
Unit of Measure: months
22.75
(18.94 to 26.63)
19.76
(18.38 to 24.00)
18.02
(14.76 to 20.61)
5.Secondary Outcome
Title Percentage of Participants With Treatment Failure
Hide Description Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 101 102 103
Measure Type: Number
Unit of Measure: percentage of participants
100.0 99.02 99.03
6.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; only participants with a treatment failure event were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 101 101 102
Median (95% Confidence Interval)
Unit of Measure: months
6.67
(5.82 to 7.56)
6.87
(5.49 to 8.38)
5.75
(4.34 to 7.27)
7.Secondary Outcome
Title Percentage of Participants With Progression Excluding Deaths
Hide Description The failure event was defined as tumor progression excluding deaths due to any reason.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 101 102 103
Measure Type: Number
Unit of Measure: percentage of participants
71.29 81.37 75.73
8.Secondary Outcome
Title Time to Progression Excluding Deaths
Hide Description The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 72 83 78
Median (95% Confidence Interval)
Unit of Measure: months
8.81
(7.66 to 10.82)
8.48
(6.90 to 8.84)
7.40
(4.87 to 9.17)
9.Secondary Outcome
Title Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer
Hide Description The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 101 102 103
Measure Type: Number
Unit of Measure: percentage of participants
81.19 90.20 85.44
10.Secondary Outcome
Title Time to Progression Excluding Deaths Not Related to Underlying Cancer
Hide Description The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 82 92 88
Median (95% Confidence Interval)
Unit of Measure: months
8.68
(7.59 to 9.90)
8.32
(6.74 to 8.75)
7.27
(4.57 to 9.11)
11.Secondary Outcome
Title Percentage of Participants by Best Overall Response
Hide Description Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; All participants with evaluable data were included in the analysis
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 91 92 94
Measure Type: Number
Unit of Measure: percentage of participants
CR 5.49 1.09 5.32
PR 46.15 32.61 28.72
SD 39.56 52.17 45.74
PD 8.79 14.13 20.21
12.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of CR or PR
Hide Description CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; All participants with evaluable data were included in the analysis
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 91 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.0
(41.0 to 62.0)
34.0
(24.0 to 44.0)
34.0
(25.0 to 45.0)
13.Secondary Outcome
Title Percentage of Participants With Stable Disease
Hide Description Stable disease rate was the proportion of participants who achieved CR, PR, or SD.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; All participants with evaluable data were included in the analysis
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 91 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.0
(83.0 to 96.0)
86.0
(77.0 to 92.0)
80.0
(70.0 to 87.0)
14.Secondary Outcome
Title Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment
Hide Description Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.
Time Frame Randomization, Weeks 3, 6 and 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; All participants with evaluable data were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 91 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.0
(4.0 to 17.0)
13.0
(7.0 to 22.0)
18.0
(11.0 to 27.0)
15.Secondary Outcome
Title Duration of Overall Response
Hide Description Duration of overall response included participants who achieved a CR or PR.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; only participants with a best overall response of CR or PR were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 47 31 32
Median (95% Confidence Interval)
Unit of Measure: months
6.51
(5.36 to 8.35)
6.61
(6.15 to 8.28)
9.12
(6.48 to 16.08)
16.Secondary Outcome
Title Duration of Stable Disease (SD)
Hide Description Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 83 79 75
Median (95% Confidence Interval)
Unit of Measure: months
8.81
(7.86 to 10.55)
8.65
(7.99 to 9.34)
8.98
(7.30 to 9.99)
17.Secondary Outcome
Title Duration of Overall Complete Response
Hide Description Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.
Time Frame Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only participants with a best overall response were included in the analysis.
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description:
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Overall Number of Participants Analyzed 5 1 5
Median (95% Confidence Interval)
Unit of Measure: months
8.35 [1] 
(5.16 to NA)
6.05 [2] 
(NA to NA)
12.89
(7.63 to 33.04)
[1]
Upper limit of the 95% confidence interval was not estimable as the duration of follow-up was not sufficient.
[2]
Number of participants analyzed for this parameter in this treatment group was 1, therefore 95% CI could not be determined.
Time Frame Adverse events were recorded from the date of randomization until the End of Study or until death in safety population. Safety population included all participants who signed informed consent and took at least one dose of each drug of study combination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Hide Arm/Group Description Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
All-Cause Mortality
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/100 (38.00%)   21/99 (21.21%)   20/102 (19.61%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  3/100 (3.00%)  0/99 (0.00%)  0/102 (0.00%) 
Neutropenia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Disseminated intravascular coagulation * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Leukopenia * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Pancytopenia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Thrombocytopenia * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Cardiac disorders       
Arrhythmia * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Cardiac failure * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Myocardial infarction * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Myocardial ischemia * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Supraventricular tachycardia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  7/100 (7.00%)  1/99 (1.01%)  1/102 (0.98%) 
Intestinal obstruction * 1  6/100 (6.00%)  0/99 (0.00%)  2/102 (1.96%) 
Vomiting * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Abdominal haematoma * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Abdominal pain * 1  1/100 (1.00%)  2/99 (2.02%)  2/102 (1.96%) 
Gastrointestinal disorder * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Intestinal haemorrhage * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Intestinal prolapse * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Nausea * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Pancreatitis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Rectal haemorrhage * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Subileus * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Swollen tongue * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
General disorders       
Chest pain * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Disease progression * 1  0/100 (0.00%)  1/99 (1.01%)  2/102 (1.96%) 
General physical health deterioration * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Mucosal inflammation * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Pyrexia * 1  3/100 (3.00%)  1/99 (1.01%)  1/102 (0.98%) 
Sudden death * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Hepatobiliary disorders       
Jaundice cholestatic * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Infections and infestations       
Central line infection * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Infection * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Septic shock * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Tuberculosis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Injury, poisoning and procedural complications       
Device migration * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Wound dehiscence * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Metabolism and nutrition disorders       
Anorexia * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Dehydration * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung squamous cell carcinoma stage unspecified * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Nervous system disorders       
Cerebral ischaemia * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Dizziness * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Spinal cord compression * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Syncope * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Renal and urinary disorders       
Calculus urinary * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Hydronephrosis * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Nephrotic syndrome * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Renal failure * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Renal vein thrombosis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders       
Pharyngeal oedema * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Pneumonitis * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Productive cough * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Pulmonary artery thrombosis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Pulmonary embolism * 1  2/100 (2.00%)  2/99 (2.02%)  0/102 (0.00%) 
Pulmonary microemboll * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Respiratory failure * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Surgical and medical procedures       
Toe amputation * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  2/100 (2.00%)  3/99 (3.03%)  0/102 (0.00%) 
Embolism * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Hypertension * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab + Capecitabine (650 mg/m^2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   95/100 (95.00%)   88/99 (88.89%)   85/102 (83.33%) 
Blood and lymphatic system disorders       
Anaemia * 1  18/100 (18.00%)  7/99 (7.07%)  6/102 (5.88%) 
Leukopenia * 1  7/100 (7.00%)  2/99 (2.02%)  2/102 (1.96%) 
Neutropenia * 1  33/100 (33.00%)  5/99 (5.05%)  6/102 (5.88%) 
Thrombocytopenia * 1  5/100 (5.00%)  1/99 (1.01%)  2/102 (1.96%) 
Febrile neutropenia * 1  3/100 (3.00%)  1/99 (1.01%)  0/102 (0.00%) 
Granulocytopenia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Leukocytosis * 1  1/100 (1.00%)  1/99 (1.01%)  1/102 (0.98%) 
Pancytopenia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Cardiac disorders       
Arrhythmia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Atrial tachycardia * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Bradycardia * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Cyanosis * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Extrasystoles * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Palpitations * 1  0/100 (0.00%)  2/99 (2.02%)  1/102 (0.98%) 
Sinus tachycardia * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Tachycardia * 1  0/100 (0.00%)  2/99 (2.02%)  1/102 (0.98%) 
Ventricular extrasystoles * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Ear and labyrinth disorders       
Ear pain * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Vertigo * 1  1/100 (1.00%)  2/99 (2.02%)  3/102 (2.94%) 
Endocrine disorders       
Hypothyroidism * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Eye disorders       
Conjunctivitis * 1  1/100 (1.00%)  6/99 (6.06%)  2/102 (1.96%) 
Conjunctival haemorrhage * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Diplopia * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Eye inflammation * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Glaucoma * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Ocular discomfort * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Ocular icterus * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Vision blurred * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  21/100 (21.00%)  11/99 (11.11%)  21/102 (20.59%) 
Abdominal pain upper * 1  13/100 (13.00%)  8/99 (8.08%)  8/102 (7.84%) 
Constipation * 1  12/100 (12.00%)  10/99 (10.10%)  8/102 (7.84%) 
Diarrhoea * 1  56/100 (56.00%)  34/99 (34.34%)  28/102 (27.45%) 
Nausea * 1  35/100 (35.00%)  16/99 (16.16%)  26/102 (25.49%) 
Stomatitis * 1  6/100 (6.00%)  10/99 (10.10%)  2/102 (1.96%) 
Vomiting * 1  23/100 (23.00%)  13/99 (13.13%)  6/102 (5.88%) 
Abdominal discomfort * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Anal discomfort * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Ano-rectal ulcer * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Ascites * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Cheilitis * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Dry mouth * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Dyspepsia * 1  4/100 (4.00%)  3/99 (3.03%)  4/102 (3.92%) 
Enteritis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Flatulence * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Gastritis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Gastrooesophageal reflux disease * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Gingival bleeding * 1  0/100 (0.00%)  2/99 (2.02%)  0/102 (0.00%) 
Gingivitis * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Haematochezia * 1  3/100 (3.00%)  1/99 (1.01%)  1/102 (0.98%) 
Haemorrhoids * 1  3/100 (3.00%)  2/99 (2.02%)  2/102 (1.96%) 
Intestinal obstruction * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Mesenteric vein thrombosis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Mouth haemorrhage * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Mouth ulceration * 1  0/100 (0.00%)  3/99 (3.03%)  0/102 (0.00%) 
Oral discomfort * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Oedema peripheral * 1  2/100 (2.00%)  1/99 (1.01%)  1/102 (0.98%) 
Periodontitis * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Polyp colorectal * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Proctalgia * 1  0/100 (0.00%)  1/99 (1.01%)  2/102 (1.96%) 
Proctitis * 1  2/100 (2.00%)  1/99 (1.01%)  1/102 (0.98%) 
Rectal haemorrhage * 1  1/100 (1.00%)  2/99 (2.02%)  2/102 (1.96%) 
Toothache * 1  1/100 (1.00%)  0/99 (0.00%)  2/102 (1.96%) 
General disorders       
Asthenia * 1  16/100 (16.00%)  17/99 (17.17%)  20/102 (19.61%) 
Fatigue * 1  14/100 (14.00%)  12/99 (12.12%)  16/102 (15.69%) 
Mucosal inflammation * 1  13/100 (13.00%)  9/99 (9.09%)  7/102 (6.86%) 
Pyrexia * 1  30/100 (30.00%)  17/99 (17.17%)  15/102 (14.71%) 
Catheter site related reaction * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Chest discomfort * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Chest pain * 1  1/100 (1.00%)  3/99 (3.03%)  4/102 (3.92%) 
Facial pain * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
General physical health deterioration * 1  1/100 (1.00%)  1/99 (1.01%)  2/102 (1.96%) 
Influenza-like illness * 1  1/100 (1.00%)  3/99 (3.03%)  1/102 (0.98%) 
Local swelling * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Malaise * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Oedema peripheral * 1  2/100 (2.00%)  1/99 (1.01%)  1/102 (0.98%) 
Pain * 1  0/100 (0.00%)  2/99 (2.02%)  1/102 (0.98%) 
Hepatobiliary disorders       
Hyperbilirubinaemia * 1  10/100 (10.00%)  22/99 (22.22%)  26/102 (25.49%) 
Hepatic failure * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Hepatic pain * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Hepatotoxicity * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Jaundice * 1  3/100 (3.00%)  0/99 (0.00%)  2/102 (1.96%) 
Infections and infestations       
Abdominal wall infection * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Bacteriuria * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Bronchitis * 1  0/100 (0.00%)  2/99 (2.02%)  2/102 (1.96%) 
Cellulitis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Cystitis * 1  1/100 (1.00%)  4/99 (4.04%)  1/102 (0.98%) 
Dental caries * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Ear infection * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Erysipelas * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Folliculitis * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Gastroenteritis viral * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Herpes zoster * 1  2/100 (2.00%)  0/99 (0.00%)  1/102 (0.98%) 
Influenza * 1  3/100 (3.00%)  4/99 (4.04%)  5/102 (4.90%) 
Nail infection * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Paronychia * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Perianal abscess * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Pharyngitis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Relapsing fever * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Rhinitis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Subcutaneous abscess * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Tooth abscess * 1  3/100 (3.00%)  1/99 (1.01%)  2/102 (1.96%) 
Urinary tract infection * 1  0/100 (0.00%)  0/99 (0.00%)  3/102 (2.94%) 
Vaginal infection * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Injury, poisoning and procedural complications       
Intestinal stoma complication * 1  1/100 (1.00%)  1/99 (1.01%)  1/102 (0.98%) 
Radius fracture * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Wound * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Wound dehiscence * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  7/100 (7.00%)  9/99 (9.09%)  12/102 (11.76%) 
Aspartate aminotransferase increased * 1  6/100 (6.00%)  8/99 (8.08%)  11/102 (10.78%) 
Blood alkaline phosphatase increased * 1  6/100 (6.00%)  4/99 (4.04%)  4/102 (3.92%) 
Blood alkaline phosphatase * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Blood bilirubin * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Blood calcium decreased * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Blood calcium increased * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Blood creatine increased * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Blood creatinine increased * 1  1/100 (1.00%)  4/99 (4.04%)  2/102 (1.96%) 
Blood glucose increased * 1  2/100 (2.00%)  1/99 (1.01%)  1/102 (0.98%) 
Blood lactate dehydrogenase increased * 1  2/100 (2.00%)  2/99 (2.02%)  1/102 (0.98%) 
Blood sodium increased * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Coagulation test abnormal * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Haematocrit decreased * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Hepatic enzyme increased * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Platelet count increased * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Prothrombin time shortened * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Transaminases increased * 1  0/100 (0.00%)  3/99 (3.03%)  0/102 (0.00%) 
Weight decreased * 1  1/100 (1.00%)  0/99 (0.00%)  2/102 (1.96%) 
Metabolism and nutrition disorders       
Anorexia * 1  9/100 (9.00%)  5/99 (5.05%)  5/102 (4.90%) 
Dehydration * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Diabetes mellitus * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Gout * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Hypercalcaemia * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Hyperglycaemia * 1  2/100 (2.00%)  1/99 (1.01%)  0/102 (0.00%) 
Hyperkalaemia * 1  2/100 (2.00%)  0/99 (0.00%)  1/102 (0.98%) 
Hypertriglyceridaemia * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Hyperuricaemia * 1  2/100 (2.00%)  1/99 (1.01%)  3/102 (2.94%) 
Hypoalbuminaemia * 1  1/100 (1.00%)  0/99 (0.00%)  2/102 (1.96%) 
Hypocalcaemia * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Hypokalaemia * 1  3/100 (3.00%)  1/99 (1.01%)  2/102 (1.96%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  5/100 (5.00%)  4/99 (4.04%)  4/102 (3.92%) 
Back pain * 1  5/100 (5.00%)  2/99 (2.02%)  4/102 (3.92%) 
Arthritis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Bone pain * 1  3/100 (3.00%)  0/99 (0.00%)  1/102 (0.98%) 
Buttock pain * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Chest wall pain * 1  0/100 (0.00%)  2/99 (2.02%)  1/102 (0.98%) 
Muscle spasms * 1  0/100 (0.00%)  0/99 (0.00%)  2/102 (1.96%) 
Musculoskeletal pain * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Myalgia * 1  1/100 (1.00%)  2/99 (2.02%)  1/102 (0.98%) 
Neck pain * 1  0/100 (0.00%)  2/99 (2.02%)  3/102 (2.94%) 
Pain in extremity * 1  2/100 (2.00%)  2/99 (2.02%)  5/102 (4.90%) 
Periarthritis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Sacral pain * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Shoulder pain * 1  3/100 (3.00%)  2/99 (2.02%)  2/102 (1.96%) 
Tendonitis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Nervous system disorders       
Headache * 1  4/100 (4.00%)  7/99 (7.07%)  5/102 (4.90%) 
Cholinergic syndrome * 1  5/100 (5.00%)  0/99 (0.00%)  0/102 (0.00%) 
Carpal tunnel syndrome * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Coordination abnormal * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Dizziness * 1  3/100 (3.00%)  0/99 (0.00%)  1/102 (0.98%) 
Dysaesthesia * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Dysguesia * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Migraine without aura * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Neuropathy * 1  3/100 (3.00%)  0/99 (0.00%)  1/102 (0.98%) 
Paraesthesia * 1  4/100 (4.00%)  3/99 (3.03%)  5/102 (4.90%) 
Sciatica * 1  1/100 (1.00%)  3/99 (3.03%)  2/102 (1.96%) 
Somnolence * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Syncope * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Psychiatric disorders       
Anxiety * 1  0/100 (0.00%)  3/99 (3.03%)  1/102 (0.98%) 
Confusional state * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Depression * 1  1/100 (1.00%)  1/99 (1.01%)  3/102 (2.94%) 
Insomnia * 1  2/100 (2.00%)  2/99 (2.02%)  1/102 (0.98%) 
Mood altered * 1  0/100 (0.00%)  1/99 (1.01%)  1/102 (0.98%) 
Panic attack * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Restlessness * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Renal and urinary disorders       
Bladder spasm * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Dysuria * 1  2/100 (2.00%)  0/99 (0.00%)  0/102 (0.00%) 
Nocturia * 1  1/100 (1.00%)  0/99 (0.00%)  1/102 (0.98%) 
Pollakiuria * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Proteinuria * 1  4/100 (4.00%)  4/99 (4.04%)  4/102 (3.92%) 
Renal colic * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Renal failure acute * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Ureteric obstruction * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Ureteric stenosis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Reproductive system and breast disorders       
Female genital-digestive tract fistula * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Pelvic pain * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Penis disorder * 1  0/100 (0.00%)  3/99 (3.03%)  1/102 (0.98%) 
Vaginal haemorrhage * 1  0/100 (0.00%)  0/99 (0.00%)  2/102 (1.96%) 
Rhinorrhoea * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  5/100 (5.00%)  3/99 (3.03%)  6/102 (5.88%) 
Dyspnoea * 1  4/100 (4.00%)  5/99 (5.05%)  6/102 (5.88%) 
Epistaxis * 1  14/100 (14.00%)  6/99 (6.06%)  7/102 (6.86%) 
Dysphonia * 1  1/100 (1.00%)  0/99 (0.00%)  2/102 (1.96%) 
Haemoptysis * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Pharyngolaryngeal pain * 1  4/100 (4.00%)  3/99 (3.03%)  1/102 (0.98%) 
Pleural effusion * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Productive cough * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Sleep apnoea syndrome * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  22/100 (22.00%)  2/99 (2.02%)  3/102 (2.94%) 
Erythema * 1  5/100 (5.00%)  0/99 (0.00%)  1/102 (0.98%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  16/100 (16.00%)  40/99 (40.40%)  39/102 (38.24%) 
Dry skin * 1  0/100 (0.00%)  2/99 (2.02%)  0/102 (0.00%) 
Hyperhidrosis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Nail disorder * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Nail dystrophy * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Onycholysis * 1  0/100 (0.00%)  2/99 (2.02%)  0/102 (0.00%) 
Photosensitivity reaction * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Pruritus * 1  0/100 (0.00%)  1/99 (1.01%)  2/102 (1.96%) 
Rash * 1  3/100 (3.00%)  1/99 (1.01%)  3/102 (2.94%) 
Rash papular * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Skin exfoliation * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Skin fissures * 1  0/100 (0.00%)  2/99 (2.02%)  0/102 (0.00%) 
Urticaria * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Surgical and medical procedures       
Cataract operation * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Inguinal hernia repair * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Stent placement * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Tooth extraction * 1  0/100 (0.00%)  1/99 (1.01%)  0/102 (0.00%) 
Vascular disorders       
Hypertension * 1  28/100 (28.00%)  29/99 (29.29%)  19/102 (18.63%) 
Axillary vein thrombosis * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Deep vein thrombosis * 1  3/100 (3.00%)  1/99 (1.01%)  1/102 (0.98%) 
Haemorrhage * 1  0/100 (0.00%)  0/99 (0.00%)  1/102 (0.98%) 
Hypotension * 1  1/100 (1.00%)  1/99 (1.01%)  0/102 (0.00%) 
Phlebitis * 1  1/100 (1.00%)  0/99 (0.00%)  0/102 (0.00%) 
Thrombosis * 1  2/100 (2.00%)  0/99 (0.00%)  1/102 (0.98%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.1)
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 after the first publication or presentation that involves the overall study. 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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01131078     History of Changes
Other Study ID Numbers: ML18524
First Submitted: April 20, 2010
First Posted: May 26, 2010
Results First Submitted: December 19, 2014
Results First Posted: December 31, 2014
Last Update Posted: June 4, 2015