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Trial record 47 of 126 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00265850
Recruitment Status : Unknown
Verified March 2017 by Alliance for Clinical Trials in Oncology.
Recruitment status was:  Active, not recruiting
First Posted : December 15, 2005
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Bristol-Myers Squibb
Aptuit Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: bevacizumab
Biological: cetuximab
Drug: FOLFOX or
Drug: FOLFIRI
Enrollment 2334
Recruitment Details  
Pre-assignment Details From 5/2005 to 9/2009, patients were randomized 1:1:1 to Arms A, B and C. Study was amended in 2009 to include only KRAS wild type patients; then Arm C was closed based on data showing no benefit from chemo with the combination of Bevacizumab and an EGFR antibody. Thereafter, only KRAS wild type patients were randomized 1:1 to Arm A and B.
Arm/Group Title Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Hide Arm/Group Description

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Period Title: Overall Study
Started 899 902 533
Completed 899 902 533
Not Completed 0 0 0
Arm/Group Title Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab Total
Hide Arm/Group Description

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Total of all reporting groups
Overall Number of Baseline Participants 559 578 0 1137
Hide Baseline Analysis Population Description
During the trial, it was learned that KRAS mutation predicted for lack of efficacy of EGFR antibodies; also studies showed no benefit from chemo combined with both Bevacizumab and an EGFR antibody. The trial was amended to 2 arms limited to KRAS wild type patients. Only confirmed and consented KRAS wild type patients were analyzed.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 559 participants 578 participants 0 participants 1137 participants
59
(21.8 to 85)
59.2
(20.8 to 89.5)
59.1
(20.8 to 89.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 559 participants 578 participants 0 participants 1137 participants
Female
211
  37.7%
229
  39.6%
440
  38.7%
Male
348
  62.3%
349
  60.4%
697
  61.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 559 participants 578 participants 0 participants 1137 participants
Canada 32 32 64
United States 527 546 1073
1.Primary Outcome
Title Overall Survival
Hide Description Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.
Time Frame Up to 5 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible KRAS wild type patients that began treatment were included in this endpoint.
Arm/Group Title Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Hide Arm/Group Description:

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Overall Number of Participants Analyzed 559 578 0
Median (95% Confidence Interval)
Unit of Measure: months
29.0
(25.6 to 31.2)
30.0
(27.5 to 32.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: FOLFOX or FOLFIRI + Bevacizumab, Arm B: FOLFOX or FOLFIRI + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.77 to 1.01
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.
Time Frame Up to 5 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible KRAS wild type patients were included in this analysis.
Arm/Group Title Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
Hide Arm/Group Description:

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Overall Number of Participants Analyzed 559 578 0
Median (95% Confidence Interval)
Unit of Measure: months
10.6
(9.5 to 11.1)
10.5
(9.5 to 11.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: FOLFOX or FOLFIRI + Bevacizumab, Arm B: FOLFOX or FOLFIRI + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.84 to 1.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description [Not Specified]
Time Frame Up to 5 years post-treatment
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Tumor Response
Hide Description [Not Specified]
Time Frame Up to 5 years post-treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
 
Arm/Group Title Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab
Hide Arm/Group Description

Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.

FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours

FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours.

All-Cause Mortality
Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/559 (17.53%)      111/578 (19.20%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Hemoglobin decreased  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Thrombotic microangiopathy  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Cardiac disorders     
Arrhythmia supraventricular  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Left ventricular failure  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Myocardial ischemia  1  3/559 (0.54%)  3 1/578 (0.17%)  1
Eye disorders     
Eye disorder  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Gastrointestinal disorders     
Abdominal pain  1  3/559 (0.54%)  3 2/578 (0.35%)  2
Ascites  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Colitis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Colonic obstruction  1  0/559 (0.00%)  0 3/578 (0.52%)  3
Colonic perforation  1  3/559 (0.54%)  3 0/578 (0.00%)  0
Constipation  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Diarrhea  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Duodenal hemorrhage  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Ear, nose and throat examination abnormal  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Esophagitis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Gastric hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Gastrointestinal disorder  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Ileal obstruction  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Ileus  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Jejunal perforation  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Obstruction gastric  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Rectal hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Rectal pain  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Small intestinal obstruction  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Small intestinal perforation  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Vomiting  1  1/559 (0.18%)  1 0/578 (0.00%)  0
General disorders     
Death NOS  1  5/559 (0.89%)  5 2/578 (0.35%)  2
Disease progression  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Fatigue  1  4/559 (0.72%)  4 3/578 (0.52%)  3
Sudden death  1  2/559 (0.36%)  2 2/578 (0.35%)  2
Hepatobiliary disorders     
Hepatic failure  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Immune system disorders     
Cytokine release syndrome  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Hypersensitivity  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Infections and infestations     
Abdominal infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Ileal infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Infection  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Sepsis  1  0/559 (0.00%)  0 4/578 (0.69%)  4
Injury, poisoning and procedural complications     
Arterial injury  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Vascular access complication  1  2/559 (0.36%)  3 7/578 (1.21%)  9
Wound dehiscence  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Investigations     
Blood bilirubin increased  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Carbon monoxide diffusing capacity decreased  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Cardiac troponin I increased  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Creatinine increased  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Leukocyte count decreased  1  2/559 (0.36%)  2 2/578 (0.35%)  2
Lymphocyte count decreased  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Neutrophil count decreased  1  35/559 (6.26%)  38 36/578 (6.23%)  43
Platelet count decreased  1  2/559 (0.36%)  2 3/578 (0.52%)  3
Serum cholesterol increased  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Blood glucose increased  1  1/559 (0.18%)  1 4/578 (0.69%)  5
Blood uric acid increased  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Dehydration  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Serum glucose decreased  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Serum magnesium decreased  1  0/559 (0.00%)  0 5/578 (0.87%)  12
Serum phosphate decreased  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Serum potassium decreased  1  2/559 (0.36%)  2 2/578 (0.35%)  2
Serum potassium increased  1  1/559 (0.18%)  2 1/578 (0.17%)  1
Serum sodium decreased  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Serum sodium increased  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Nervous system disorders     
Intracranial hemorrhage  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Ischemia cerebrovascular  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Peripheral sensory neuropathy  1  3/559 (0.54%)  3 1/578 (0.17%)  1
Seizure  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Psychiatric disorders     
Confusion  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Depression  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Psychosis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Renal and urinary disorders     
Proteinuria  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Renal failure  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Hypoxia  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Pneumonitis  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Respiratory disorder  1  0/559 (0.00%)  0 4/578 (0.69%)  4
Skin and subcutaneous tissue disorders     
Hand-and-foot syndrome  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Rash desquamating  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Vascular disorders     
Hypertension  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Hypotension  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Thrombosis  1  14/559 (2.50%)  14 22/578 (3.81%)  39
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: FOLFOX or FOLFIRI + Bevacizumab Arm B: FOLFOX or FOLFIRI + Cetuximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   531/559 (94.99%)      548/578 (94.81%)    
Blood and lymphatic system disorders     
Blood disorder  1  0/559 (0.00%)  0 4/578 (0.69%)  4
Disseminated intravascular coagulation  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Febrile neutropenia  1  5/559 (0.89%)  5 10/578 (1.73%)  10
Hemoglobin decreased  1  95/559 (16.99%)  161 83/578 (14.36%)  145
Hemolysis  1  7/559 (1.25%)  7 5/578 (0.87%)  6
Lymph node pain  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Lymphatic disorder  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Cardiac disorders     
Atrial fibrillation  1  3/559 (0.54%)  3 5/578 (0.87%)  5
Atrial flutter  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Atrial tachycardia  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Cardiac disorder  1  5/559 (0.89%)  5 1/578 (0.17%)  1
Cardiac pain  1  4/559 (0.72%)  4 5/578 (0.87%)  5
Conduction disorder  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Left ventricular failure  1  2/559 (0.36%)  2 3/578 (0.52%)  6
Myocardial ischemia  1  3/559 (0.54%)  3 5/578 (0.87%)  5
Myocarditis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Nodal arrhythmia  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Palpitations  1  2/559 (0.36%)  2 3/578 (0.52%)  3
Pericarditis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Sinus bradycardia  1  2/559 (0.36%)  2 2/578 (0.35%)  2
Sinus tachycardia  1  2/559 (0.36%)  2 5/578 (0.87%)  5
Supraventricular tachycardia  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Ventricular trigeminy  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Ear and labyrinth disorders     
Ear disorder  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Ear pain  1  1/559 (0.18%)  2 1/578 (0.17%)  1
External ear inflammation  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Hearing impaired  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Hearing test abnormal  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Middle ear inflammation  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Tinnitus  1  4/559 (0.72%)  5 4/578 (0.69%)  7
Endocrine disorders     
Adrenal insufficiency  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Cushingoid  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Hyperthyroidism  1  1/559 (0.18%)  2 1/578 (0.17%)  1
Hypothyroidism  1  1/559 (0.18%)  2 1/578 (0.17%)  1
Eye disorders     
Cataract  1  3/559 (0.54%)  3 1/578 (0.17%)  3
Conjunctivitis  1  3/559 (0.54%)  4 12/578 (2.08%)  23
Diplopia  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Dry eye syndrome  1  1/559 (0.18%)  1 1/578 (0.17%)  3
Extraocular muscle paresis  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Eye disorder  1  0/559 (0.00%)  0 4/578 (0.69%)  7
Eye pain  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Eyelid function disorder  1  0/559 (0.00%)  0 2/578 (0.35%)  6
Glaucoma  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Keratitis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Retinopathy  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Vision blurred  1  3/559 (0.54%)  5 2/578 (0.35%)  10
Watering eyes  1  1/559 (0.18%)  1 4/578 (0.69%)  8
Gastrointestinal disorders     
Abdominal distension  1  4/559 (0.72%)  4 4/578 (0.69%)  4
Abdominal pain  1  189/559 (33.81%)  377 186/578 (32.18%)  327
Anal exam abnormal  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Anal fistula  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Anal hemorrhage  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Anal mucositis  1  0/559 (0.00%)  0 1/578 (0.17%)  3
Anal pain  1  3/559 (0.54%)  5 3/578 (0.52%)  6
Ascites  1  3/559 (0.54%)  3 2/578 (0.35%)  2
Cheilitis  1  2/559 (0.36%)  3 5/578 (0.87%)  5
Colitis  1  1/559 (0.18%)  1 3/578 (0.52%)  3
Colonic fistula  1  2/559 (0.36%)  5 1/578 (0.17%)  1
Colonic hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Colonic obstruction  1  5/559 (0.89%)  5 6/578 (1.04%)  6
Colonic perforation  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Constipation  1  41/559 (7.33%)  57 58/578 (10.03%)  91
Diarrhea  1  304/559 (54.38%)  751 346/578 (59.86%)  804
Dry mouth  1  1/559 (0.18%)  2 7/578 (1.21%)  10
Duodenal fistula  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Duodenal hemorrhage  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Duodenal obstruction  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Duodenal ulcer  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Dyspepsia  1  23/559 (4.11%)  27 19/578 (3.29%)  57
Dysphagia  1  9/559 (1.61%)  9 6/578 (1.04%)  6
Ear, nose and throat examination abnormal  1  21/559 (3.76%)  28 54/578 (9.34%)  71
Endoscopy small intestine abnormal  1  1/559 (0.18%)  1 1/578 (0.17%)  3
Enteritis  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Esophageal hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Esophageal ulcer  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Esophagitis  1  3/559 (0.54%)  5 4/578 (0.69%)  4
Fecal incontinence  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Fistula of small intestine  1  2/559 (0.36%)  3 0/578 (0.00%)  0
Flatulence  1  6/559 (1.07%)  11 11/578 (1.90%)  12
Gastric hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Gastric stenosis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Gastric ulcer  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Gastritis  1  4/559 (0.72%)  7 6/578 (1.04%)  25
Gastrointestinal disorder  1  6/559 (1.07%)  11 8/578 (1.38%)  9
Gingival pain  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Hemorrhoids  1  12/559 (2.15%)  18 13/578 (2.25%)  16
Ileal obstruction  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Ileus  1  6/559 (1.07%)  8 1/578 (0.17%)  1
Intestinal necrosis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Jejunal obstruction  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Lip pain  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Mucositis oral  1  44/559 (7.87%)  57 59/578 (10.21%)  102
Nausea  1  90/559 (16.10%)  114 100/578 (17.30%)  154
Obstruction gastric  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Oral hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Oral pain  1  2/559 (0.36%)  3 4/578 (0.69%)  5
Pancreatitis  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Periodontal disease  1  1/559 (0.18%)  3 2/578 (0.35%)  6
Peritoneal hemorrhage  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Proctitis  1  3/559 (0.54%)  3 0/578 (0.00%)  0
Rectal hemorrhage  1  5/559 (0.89%)  6 3/578 (0.52%)  3
Rectal mucositis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Rectal pain  1  15/559 (2.68%)  27 7/578 (1.21%)  12
Rectal stenosis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Rectal ulcer  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Salivary gland disorder  1  2/559 (0.36%)  4 0/578 (0.00%)  0
Small intestinal mucositis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Small intestinal necrosis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Small intestinal obstruction  1  7/559 (1.25%)  7 7/578 (1.21%)  7
Small intestinal perforation  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Small intestine ulcer  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Stomach pain  1  0/559 (0.00%)  0 2/578 (0.35%)  4
Tooth disorder  1  1/559 (0.18%)  2 4/578 (0.69%)  4
Toothache  1  4/559 (0.72%)  4 3/578 (0.52%)  3
Upper gastrointestinal hemorrhage  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Vomiting  1  174/559 (31.13%)  284 185/578 (32.01%)  265
General disorders     
Chest pain  1  11/559 (1.97%)  15 7/578 (1.21%)  7
Chills  1  43/559 (7.69%)  51 62/578 (10.73%)  88
Edema limbs  1  7/559 (1.25%)  7 9/578 (1.56%)  15
Facial pain  1  1/559 (0.18%)  1 5/578 (0.87%)  5
Fatigue  1  397/559 (71.02%)  1213 418/578 (72.32%)  1315
Fever  1  75/559 (13.42%)  101 67/578 (11.59%)  83
Flu-like symptoms  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Gait abnormal  1  1/559 (0.18%)  1 1/578 (0.17%)  1
General symptom  1  6/559 (1.07%)  7 5/578 (0.87%)  8
Injection site reaction  1  2/559 (0.36%)  3 3/578 (0.52%)  3
Localized edema  1  2/559 (0.36%)  3 1/578 (0.17%)  1
Pain  1  28/559 (5.01%)  39 30/578 (5.19%)  32
Pericardial pain  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Hepatobiliary disorders     
Bile duct stenosis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Cholecystitis  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Gallbladder pain  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Hepatic failure  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Hepatobiliary disease  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Portal hypertension  1  0/559 (0.00%)  0 3/578 (0.52%)  3
Immune system disorders     
Cytokine release syndrome  1  22/559 (3.94%)  29 56/578 (9.69%)  61
Hypersensitivity  1  13/559 (2.33%)  14 15/578 (2.60%)  20
Infections and infestations     
Abdominal infection  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Anal infection  1  1/559 (0.18%)  3 2/578 (0.35%)  3
Anorectal infection  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Biliary tract infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Bladder infection  1  10/559 (1.79%)  14 7/578 (1.21%)  8
Bone infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Bronchitis  1  4/559 (0.72%)  7 1/578 (0.17%)  1
Catheter related infection  1  14/559 (2.50%)  17 10/578 (1.73%)  10
Colitis, infectious (e.g., Clostridium difficile)  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Conjunctivitis infective  1  1/559 (0.18%)  1 6/578 (1.04%)  7
Device related infection  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Esophageal infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Eye infection  1  2/559 (0.36%)  2 2/578 (0.35%)  5
Gingival infection  1  5/559 (0.89%)  6 0/578 (0.00%)  0
Infection  1  16/559 (2.86%)  19 17/578 (2.94%)  22
Infection with unknown ANC  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Infection without neutropenia  1  2/559 (0.36%)  2 2/578 (0.35%)  3
Infectious colitis  1  1/559 (0.18%)  1 3/578 (0.52%)  3
Infectious meningitis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Joint infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Kidney infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Laryngitis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Lip infection  1  2/559 (0.36%)  2 2/578 (0.35%)  2
Lymph gland infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Mediastinal infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Mucosal infection  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Nail infection  1  0/559 (0.00%)  0 16/578 (2.77%)  30
Opportunistic infection  1  3/559 (0.54%)  3 1/578 (0.17%)  1
Otitis externa  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Otitis media  1  3/559 (0.54%)  3 1/578 (0.17%)  1
Paranasal sinus infection  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Pelvic infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Penile infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Peripheral nerve infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Peritoneal infection  1  3/559 (0.54%)  3 1/578 (0.17%)  1
Pharyngitis  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Pneumonia  1  7/559 (1.25%)  7 8/578 (1.38%)  10
Rhinitis infective  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Salivary gland infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Scrotal infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Sepsis  1  3/559 (0.54%)  3 5/578 (0.87%)  5
Sinusitis  1  7/559 (1.25%)  9 3/578 (0.52%)  4
Skin infection  1  5/559 (0.89%)  6 19/578 (3.29%)  24
Small intestine infection  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Soft tissue infection  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Stoma site infection  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Tooth infection  1  8/559 (1.43%)  11 4/578 (0.69%)  5
Upper aerodigestive tract infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Upper respiratory infection  1  10/559 (1.79%)  16 7/578 (1.21%)  9
Urethral infection  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Urinary tract infection  1  24/559 (4.29%)  27 19/578 (3.29%)  21
Vaginal infection  1  3/559 (0.54%)  4 0/578 (0.00%)  0
Wound infection  1  4/559 (0.72%)  5 6/578 (1.04%)  7
Wound-infectious  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Injury, poisoning and procedural complications     
Aortic injury  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Arterial injury  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Esophageal anastomotic leak  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Fracture  1  3/559 (0.54%)  3 5/578 (0.87%)  6
Intestinal stoma site bleeding  1  2/559 (0.36%)  2 0/578 (0.00%)  0
Intraoperative gastrointestinal injury  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Radiation recall reaction (dermatologic)  1  0/559 (0.00%)  0 5/578 (0.87%)  5
Seroma  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Vascular access complication  1  14/559 (2.50%)  24 21/578 (3.63%)  33
Wound dehiscence  1  5/559 (0.89%)  7 1/578 (0.17%)  2
Investigations     
Activated partial thromboplastin time prolonged  1  0/559 (0.00%)  0 3/578 (0.52%)  3
Alanine aminotransferase increased  1  16/559 (2.86%)  29 23/578 (3.98%)  38
Alkaline phosphatase  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Alkaline phosphatase increased  1  32/559 (5.72%)  49 35/578 (6.06%)  58
Amylase increased  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Aspartate aminotransferase increased  1  11/559 (1.97%)  15 21/578 (3.63%)  34
Blood bilirubin increased  1  45/559 (8.05%)  84 57/578 (9.86%)  108
Blood gonadotrophin abnormal  1  1/559 (0.18%)  2 0/578 (0.00%)  0
CD4 lymphocytes decreased  1  0/559 (0.00%)  0 1/578 (0.17%)  4
Cardiac troponin T increased  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Coagulopathy  1  0/559 (0.00%)  0 2/578 (0.35%)  6
Creatinine increased  1  21/559 (3.76%)  25 7/578 (1.21%)  8
Electrocardiogram QTc interval prolonged  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Fibrinogen decreased  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Gamma-glutamyltransferase increased  1  0/559 (0.00%)  0 4/578 (0.69%)  9
INR increased  1  10/559 (1.79%)  14 18/578 (3.11%)  40
Laboratory test abnormal  1  2/559 (0.36%)  2 7/578 (1.21%)  8
Leukocyte count decreased  1  79/559 (14.13%)  144 98/578 (16.96%)  150
Lipase increased  1  1/559 (0.18%)  1 4/578 (0.69%)  4
Lymphocyte count decreased  1  29/559 (5.19%)  68 31/578 (5.36%)  60
Neutrophil count decreased  1  316/559 (56.53%)  716 334/578 (57.79%)  792
Platelet count decreased  1  208/559 (37.21%)  541 210/578 (36.33%)  575
Serum cholesterol increased  1  1/559 (0.18%)  2 3/578 (0.52%)  11
Weight gain  1  10/559 (1.79%)  30 9/578 (1.56%)  21
Weight loss  1  35/559 (6.26%)  49 63/578 (10.90%)  113
Metabolism and nutrition disorders     
Anorexia  1  71/559 (12.70%)  92 100/578 (17.30%)  142
Blood bicarbonate decreased  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Blood glucose increased  1  75/559 (13.42%)  141 80/578 (13.84%)  161
Dehydration  1  53/559 (9.48%)  62 53/578 (9.17%)  66
Glucose intolerance  1  1/559 (0.18%)  1 2/578 (0.35%)  4
Serum albumin decreased  1  64/559 (11.45%)  87 62/578 (10.73%)  90
Serum calcium decreased  1  25/559 (4.47%)  26 36/578 (6.23%)  51
Serum calcium increased  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Serum glucose decreased  1  5/559 (0.89%)  7 5/578 (0.87%)  6
Serum magnesium decreased  1  56/559 (10.02%)  97 231/578 (39.97%)  685
Serum magnesium increased  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Serum phosphate decreased  1  10/559 (1.79%)  14 25/578 (4.33%)  35
Serum potassium decreased  1  29/559 (5.19%)  37 56/578 (9.69%)  72
Serum potassium increased  1  4/559 (0.72%)  4 10/578 (1.73%)  11
Serum sodium decreased  1  16/559 (2.86%)  24 10/578 (1.73%)  11
Serum sodium increased  1  3/559 (0.54%)  3 3/578 (0.52%)  3
Serum triglycerides increased  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  27/559 (4.83%)  56 14/578 (2.42%)  18
Arthritis  1  1/559 (0.18%)  2 3/578 (0.52%)  4
Back pain  1  29/559 (5.19%)  56 29/578 (5.02%)  45
Bone pain  1  6/559 (1.07%)  12 9/578 (1.56%)  13
Buttock pain  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Chest wall pain  1  2/559 (0.36%)  2 3/578 (0.52%)  3
Joint disorder  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Joint effusion  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Muscle weakness  1  4/559 (0.72%)  4 15/578 (2.60%)  17
Muscle weakness lower limb  1  4/559 (0.72%)  5 4/578 (0.69%)  5
Musculoskeletal disorder  1  3/559 (0.54%)  3 5/578 (0.87%)  9
Myalgia  1  10/559 (1.79%)  12 11/578 (1.90%)  17
Neck pain  1  5/559 (0.89%)  7 4/578 (0.69%)  4
Osteoporosis  1  0/559 (0.00%)  0 1/578 (0.17%)  5
Pain in extremity  1  20/559 (3.58%)  36 21/578 (3.63%)  28
Soft tissue necrosis upper limb  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Trismus  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Upper extremity dysfunction  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  1/559 (0.18%)  1 3/578 (0.52%)  7
Nervous system disorders     
Ataxia  1  3/559 (0.54%)  3 7/578 (1.21%)  10
Cognitive disturbance  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Depressed level of consciousness  1  4/559 (0.72%)  4 2/578 (0.35%)  2
Dizziness  1  19/559 (3.40%)  25 28/578 (4.84%)  31
Dysgeusia  1  24/559 (4.29%)  37 33/578 (5.71%)  47
Extrapyramidal disorder  1  2/559 (0.36%)  2 2/578 (0.35%)  11
Facial nerve disorder  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Headache  1  98/559 (17.53%)  209 80/578 (13.84%)  165
Ischemia cerebrovascular  1  2/559 (0.36%)  2 4/578 (0.69%)  4
Memory impairment  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Mini mental status examination abnormal  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Neuralgia  1  1/559 (0.18%)  2 1/578 (0.17%)  1
Neurological disorder NOS  1  5/559 (0.89%)  5 3/578 (0.52%)  3
Peripheral motor neuropathy  1  9/559 (1.61%)  33 12/578 (2.08%)  20
Peripheral sensory neuropathy  1  355/559 (63.51%)  1131 344/578 (59.52%)  1176
Recurrent laryngeal nerve palsy  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Seizure  1  2/559 (0.36%)  2 5/578 (0.87%)  5
Sinus pain  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Speech disorder  1  5/559 (0.89%)  7 3/578 (0.52%)  4
Syncope  1  10/559 (1.79%)  10 17/578 (2.94%)  19
Syncope vasovagal  1  1/559 (0.18%)  1 2/578 (0.35%)  2
Tremor  1  1/559 (0.18%)  1 3/578 (0.52%)  5
Trigeminal nerve disorder  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Psychiatric disorders     
Agitation  1  1/559 (0.18%)  1 3/578 (0.52%)  3
Anxiety  1  22/559 (3.94%)  47 12/578 (2.08%)  18
Confusion  1  6/559 (1.07%)  6 5/578 (0.87%)  5
Depression  1  16/559 (2.86%)  19 23/578 (3.98%)  36
Insomnia  1  26/559 (4.65%)  34 36/578 (6.23%)  65
Libido decreased  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Psychosis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Renal and urinary disorders     
Bladder hemorrhage  1  2/559 (0.36%)  2 1/578 (0.17%)  1
Bladder pain  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Bladder spasm  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Cystitis  1  0/559 (0.00%)  0 3/578 (0.52%)  3
Glomerular filtration rate decreased  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Hemoglobin urine positive  1  2/559 (0.36%)  3 0/578 (0.00%)  0
Hemorrhage urinary tract  1  2/559 (0.36%)  3 2/578 (0.35%)  2
Kidney pain  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Kidney perforation  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Proteinuria  1  159/559 (28.44%)  335 43/578 (7.44%)  62
Renal failure  1  7/559 (1.25%)  7 3/578 (0.52%)  3
Renal hemorrhage  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Ureteric hemorrhage  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Ureteric obstruction  1  0/559 (0.00%)  0 2/578 (0.35%)  7
Ureteric stenosis  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Urinary frequency  1  6/559 (1.07%)  8 4/578 (0.69%)  4
Urinary incontinence  1  0/559 (0.00%)  0 5/578 (0.87%)  9
Urinary retention  1  5/559 (0.89%)  8 2/578 (0.35%)  3
Urogenital disorder  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Reproductive system and breast disorders     
Erectile dysfunction  1  2/559 (0.36%)  3 1/578 (0.17%)  4
Gynecomastia  1  1/559 (0.18%)  2 0/578 (0.00%)  0
Pelvic pain  1  0/559 (0.00%)  0 3/578 (0.52%)  3
Prostatic obstruction  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Vaginal dryness  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Vaginal fistula  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Vaginal hemorrhage  1  2/559 (0.36%)  3 3/578 (0.52%)  4
Vaginal inflammation  1  1/559 (0.18%)  3 1/578 (0.17%)  1
Vaginal mucositis  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  9/559 (1.61%)  16 4/578 (0.69%)  4
Apnea  1  1/559 (0.18%)  2 1/578 (0.17%)  1
Aspiration  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Bronchospasm  1  2/559 (0.36%)  2 2/578 (0.35%)  4
Cough  1  17/559 (3.04%)  21 11/578 (1.90%)  29
Dyspnea  1  33/559 (5.90%)  53 37/578 (6.40%)  61
Dyspnea (shortness of breath)  1  1/559 (0.18%)  9 1/578 (0.17%)  1
Epistaxis  1  18/559 (3.22%)  29 2/578 (0.35%)  2
Hiccups  1  9/559 (1.61%)  12 4/578 (0.69%)  5
Hypoxia  1  4/559 (0.72%)  6 8/578 (1.38%)  8
Laryngeal edema  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Nasal congestion  1  3/559 (0.54%)  3 3/578 (0.52%)  4
Pharyngeal examination abnormal  1  2/559 (0.36%)  2 2/578 (0.35%)  4
Pharyngeal mucositis  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Pharyngolaryngeal pain  1  3/559 (0.54%)  3 0/578 (0.00%)  0
Pleural effusion  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Pleural hemorrhage  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Pleuritic pain  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Pneumonitis  1  5/559 (0.89%)  6 9/578 (1.56%)  9
Pneumothorax  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Respiratory disorder  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Respiratory tract hemorrhage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Tracheoscopy abnormal  1  0/559 (0.00%)  0 1/578 (0.17%)  2
Voice alteration  1  4/559 (0.72%)  12 2/578 (0.35%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  16/559 (2.86%)  35 18/578 (3.11%)  27
Body odor  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Decubitus ulcer  1  1/559 (0.18%)  1 5/578 (0.87%)  7
Dry skin  1  6/559 (1.07%)  12 38/578 (6.57%)  74
Erythema multiforme  1  3/559 (0.54%)  3 11/578 (1.90%)  18
Hand-and-foot syndrome  1  24/559 (4.29%)  53 46/578 (7.96%)  71
Nail disorder  1  6/559 (1.07%)  8 20/578 (3.46%)  40
Pain of skin  1  2/559 (0.36%)  2 7/578 (1.21%)  7
Pruritus  1  3/559 (0.54%)  4 23/578 (3.98%)  27
Rash acneiform  1  9/559 (1.61%)  15 123/578 (21.28%)  271
Rash desquamating  1  13/559 (2.33%)  16 66/578 (11.42%)  110
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Scalp pain  1  0/559 (0.00%)  0 2/578 (0.35%)  2
Skin disorder  1  5/559 (0.89%)  6 31/578 (5.36%)  53
Skin hyperpigmentation  1  6/559 (1.07%)  15 6/578 (1.04%)  16
Skin hypopigmentation  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Skin induration  1  0/559 (0.00%)  0 1/578 (0.17%)  1
Skin ulceration  1  3/559 (0.54%)  3 5/578 (0.87%)  5
Sweating  1  9/559 (1.61%)  12 7/578 (1.21%)  21
Urticaria  1  3/559 (0.54%)  4 0/578 (0.00%)  0
Vascular disorders     
Flushing  1  1/559 (0.18%)  1 1/578 (0.17%)  1
Hot flashes  1  1/559 (0.18%)  1 4/578 (0.69%)  8
Hypertension  1  179/559 (32.02%)  402 80/578 (13.84%)  184
Hypotension  1  23/559 (4.11%)  25 35/578 (6.06%)  40
Lymph leakage  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Lymphedema  1  1/559 (0.18%)  1 0/578 (0.00%)  0
Phlebitis  1  2/559 (0.36%)  3 2/578 (0.35%)  2
Thrombosis  1  44/559 (7.87%)  97 50/578 (8.65%)  95
Vascular disorder  1  2/559 (0.36%)  2 3/578 (0.52%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alan Venook, M.D.
Organization: Alliance for Clinical Trials in Oncology
EMail: Venook@cc.ucsf.edu
Other Publications:
Schrag D, Naughton M, Kesselheim A, et al.: Clinical trial participants' strategies for coping with prescription drug costs: A companion study to CALGB 80405. [Abstract] J Clin Oncol 27 (Suppl 15): A-9503, 2009.
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00265850     History of Changes
Other Study ID Numbers: CALGB 80405
U10CA037447 ( U.S. NIH Grant/Contract )
CDR0000455161 ( Other Identifier: Physician Data Query )
NCI-2009-00434 ( Registry Identifier: NCI Clinical Trial Reporting Program Office )
First Submitted: December 14, 2005
First Posted: December 15, 2005
Results First Submitted: March 13, 2017
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017