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Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer

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ClinicalTrials.gov Identifier: NCT00112918
Recruitment Status : Completed
First Posted : June 3, 2005
Results First Posted : September 6, 2012
Last Update Posted : August 27, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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 Biological: Bevacizumab
Drug: Capecitabine
Drug: 5-Fluorouracil (5-FU)
Drug: Leucovorin calcium
Drug: Oxaliplatin
Enrollment 3451
Recruitment Details  
Pre-assignment Details Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Period Title: Overall Study
Started 1151 1155 1145
Received Treatment 1126 1145 [1] 1135
Stage III Disease Population 955 960 952
Completed 854 [2] 810 [2] 846 [2]
Not Completed 297 345 299
[1]
Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis
[2]
Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv Total
Hide Arm/Group Description

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Total of all reporting groups
Overall Number of Baseline Participants 955 960 952 2867
Hide Baseline Analysis Population Description
Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 955 participants 960 participants 952 participants 2867 participants
<40 77 74 68 219
40-65 603 625 588 1816
>=65 275 261 296 832
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 955 participants 960 participants 952 participants 2867 participants
Female
425
  44.5%
473
  49.3%
432
  45.4%
1330
  46.4%
Male
530
  55.5%
487
  50.7%
520
  54.6%
1537
  53.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 955 participants 960 participants 952 participants 2867 participants
American Indian or Alaska Native 1 1 0 2
Asian 139 115 123 377
Black or African American 6 13 14 33
White 791 813 795 2399
Other 18 18 20 56
1.Primary Outcome
Title Disease-free Survival in Stage III Cancer Patients - Time to Event
Hide Description Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.
Time Frame From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description:

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Overall Number of Participants Analyzed 955 960 952
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFOX4, FOLFOX4 + Bv, XELOX+Bv
Comments Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2024
Comments [Not Specified]
Method Closed test procedure
Comments [Not Specified]
2.Primary Outcome
Title Disease-free Survival in Stage III Cancer Patients - Number of Events
Hide Description A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.
Time Frame From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description:

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Overall Number of Participants Analyzed 955 960 952
Measure Type: Number
Unit of Measure: participants
Patients with a DFS event 237 280 253
Recurrence 219 253 223
New Occurrence 3 8 6
Death 17 21 25
Patients without events 718 680 699
3.Secondary Outcome
Title Overall Survival in Stage III Cancer Patients - Time to Event
Hide Description Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.
Time Frame From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT patients with Stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description:

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Overall Number of Participants Analyzed 955 960 952
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
4.Secondary Outcome
Title Overall Survival in Stage III Cancer Patients - Number of Events
Hide Description An overall survival event was death due to any cause.
Time Frame From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT patients with Stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description:

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Overall Number of Participants Analyzed 955 960 952
Measure Type: Number
Unit of Measure: participants
Patients with events 115 151 145
Patients without events 840 809 807
5.Secondary Outcome
Title Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis
Hide Description Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.
Time Frame From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT patients with Stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description:

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Overall Number of Participants Analyzed 955 960 952
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
6.Secondary Outcome
Title Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis
Hide Description An overall survival event was death due to any cause.
Time Frame From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT patients with Stage III disease.
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description:

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Overall Number of Participants Analyzed 955 960 952
Measure Type: Number
Unit of Measure: participants
Patients with events 161 202 182
Patients without events 794 758 770
Time Frame All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Hide Arm/Group Description

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25-48: Observation only.

Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).

Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

All-Cause Mortality
FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   226/1126 (20.07%)   297/1145 (25.94%)   284/1135 (25.02%) 
Blood and lymphatic system disorders       
Neutropenia  1  18/1126 (1.60%)  18/1145 (1.57%)  0/1135 (0.00%) 
Febrile neutropenia  1  14/1126 (1.24%)  9/1145 (0.79%)  2/1135 (0.18%) 
Anaemia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Idiopathic thrombocytopenia purpura  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Leukopenia  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Thrombocytopenia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Cardiac disorders       
Myocardial infarction  1  1/1126 (0.09%)  5/1145 (0.44%)  1/1135 (0.09%) 
Angina pectoris  1  1/1126 (0.09%)  1/1145 (0.09%)  4/1135 (0.35%) 
Coronary artery disease  1  1/1126 (0.09%)  2/1145 (0.17%)  1/1135 (0.09%) 
Myocardial ischaemia  1  2/1126 (0.18%)  1/1145 (0.09%)  1/1135 (0.09%) 
Acute myocardial infarction  1  1/1126 (0.09%)  2/1145 (0.17%)  0/1135 (0.00%) 
Cardiac arrest  1  0/1126 (0.00%)  1/1145 (0.09%)  2/1135 (0.18%) 
Angina unstable  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Arteriospasm coronary  1  1/1126 (0.09%)  0/1145 (0.00%)  1/1135 (0.09%) 
Atrial fibrillation  1  2/1126 (0.18%)  0/1145 (0.00%)  0/1135 (0.00%) 
Acute coronary syndrome  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Cardiac asthma  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Cardiac failure  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Cardiac failure congestive  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Left ventricular dysfunction  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Mitral valve incompetence  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Palpitations  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Paroxysmal arrhythmia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Pericardial haemorrhage  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Sinus arrest  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Eye disorders       
Retinal detachment  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Retinal vein thrombosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Uveitis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gastrointestinal disorders       
Diarrhoea  1  28/1126 (2.49%)  28/1145 (2.45%)  62/1135 (5.46%) 
Abdominal pain  1  11/1126 (0.98%)  14/1145 (1.22%)  18/1135 (1.59%) 
Vomiting  1  7/1126 (0.62%)  11/1145 (0.96%)  16/1135 (1.41%) 
Intestinal obstruction  1  6/1126 (0.53%)  9/1145 (0.79%)  7/1135 (0.62%) 
Nausea  1  0/1126 (0.00%)  4/1145 (0.35%)  7/1135 (0.62%) 
Rectal haemorrhage  1  1/1126 (0.09%)  7/1145 (0.61%)  3/1135 (0.26%) 
Enteritis  1  3/1126 (0.27%)  0/1145 (0.00%)  5/1135 (0.44%) 
Small intestinal obstruction  1  2/1126 (0.18%)  2/1145 (0.17%)  4/1135 (0.35%) 
Constipation  1  1/1126 (0.09%)  4/1145 (0.35%)  2/1135 (0.18%) 
Subileus  1  1/1126 (0.09%)  4/1145 (0.35%)  2/1135 (0.18%) 
Colitis  1  0/1126 (0.00%)  1/1145 (0.09%)  5/1135 (0.44%) 
Abdominal adhesions  1  2/1126 (0.18%)  0/1145 (0.00%)  2/1135 (0.18%) 
Gastritis  1  3/1126 (0.27%)  1/1145 (0.09%)  0/1135 (0.00%) 
Gastrointestinal haemorrhage  1  0/1126 (0.00%)  2/1145 (0.17%)  2/1135 (0.18%) 
Gastrointestinal obstruction  1  0/1126 (0.00%)  3/1145 (0.26%)  1/1135 (0.09%) 
Haemorrhoids  1  1/1126 (0.09%)  1/1145 (0.09%)  2/1135 (0.18%) 
Oesophagitis  1  0/1126 (0.00%)  2/1145 (0.17%)  2/1135 (0.18%) 
Small intestinal perforation  1  0/1126 (0.00%)  4/1145 (0.35%)  0/1135 (0.00%) 
Enterocolitis  1  1/1126 (0.09%)  1/1145 (0.09%)  1/1135 (0.09%) 
Ileus paralytic  1  0/1126 (0.00%)  1/1145 (0.09%)  2/1135 (0.18%) 
Intestinal perforation  1  1/1126 (0.09%)  2/1145 (0.17%)  0/1135 (0.00%) 
Pancreatitis  1  2/1126 (0.18%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pancreatitis acute  1  1/1126 (0.09%)  1/1145 (0.09%)  1/1135 (0.09%) 
Peritonitis  1  0/1126 (0.00%)  1/1145 (0.09%)  2/1135 (0.18%) 
Stomatitis  1  1/1126 (0.09%)  0/1145 (0.00%)  2/1135 (0.18%) 
Abdominal distension  1  1/1126 (0.09%)  0/1145 (0.00%)  1/1135 (0.09%) 
Abdominal hernia  1  2/1126 (0.18%)  0/1145 (0.00%)  0/1135 (0.00%) 
Anal fissure  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Anal fistula  1  0/1126 (0.00%)  2/1145 (0.17%)  0/1135 (0.00%) 
Gastrointestinal necrosis  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Haematemesis  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Haematochezia  1  0/1126 (0.00%)  0/1145 (0.00%)  2/1135 (0.18%) 
Ileus  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Mechanical ileus  1  2/1126 (0.18%)  0/1145 (0.00%)  0/1135 (0.00%) 
Abdominal discomfort  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Abdominal pain lower  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Abdominal pain upper  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Abdominal rigidity  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Acute abdomen  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Caecitis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Colitis ulcerative  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Crohn's disease  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Duodenitis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Dyspepsia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Enterocolitis haemorrhagic  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Erosive oesophagitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Faecaloma  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Food poisoning  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gastric ulcer  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gastric volvulus  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gastrointestinal perforation  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Gastrooesophageal reflux disease  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Hiatus hernia, obstructive  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Ileal perforation  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Intestinal angina  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Intestinal dilatation  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Intestinal fistula  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Intestinal ischaemia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Intestinal prolapse  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Intestinal strangulation  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Large intestine perforation  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Lower gastrointestinal haemorrhage  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Mallory-Weiss syndrome  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Melaena  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Mesenteric vein thrombosis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Neutropenic colitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Rectal perforation  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Umbilical hernia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Upper gastrointestinal haemorrhage  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Volvulus of small bowel  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
General disorders       
Pyrexia  1  20/1126 (1.78%)  10/1145 (0.87%)  16/1135 (1.41%) 
Non-cardiac chest pain  1  1/1126 (0.09%)  2/1145 (0.17%)  5/1135 (0.44%) 
Sudden death  1  0/1126 (0.00%)  2/1145 (0.17%)  3/1135 (0.26%) 
Asthenia  1  0/1126 (0.00%)  3/1145 (0.26%)  1/1135 (0.09%) 
Chest pain  1  1/1126 (0.09%)  2/1145 (0.17%)  1/1135 (0.09%) 
Extravasation  1  0/1126 (0.00%)  0/1145 (0.00%)  2/1135 (0.18%) 
Medical device complication  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Multi-organ failure  1  2/1126 (0.18%)  0/1145 (0.00%)  0/1135 (0.00%) 
Thrombosis in device  1  1/1126 (0.09%)  0/1145 (0.00%)  1/1135 (0.09%) 
Adhesion  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Catheter site pain  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Chills  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Device leakage  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Device malfunction  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
General physical health deterioration  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Hernia obstructive  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Hyperpyrexia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Infusion site thrombosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Malaise  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pain  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Performance status decreased  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Sudden cardiac death  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Visceral pain  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/1126 (0.09%)  1/1145 (0.09%)  2/1135 (0.18%) 
Portal vein thrombosis  1  1/1126 (0.09%)  2/1145 (0.17%)  1/1135 (0.09%) 
Cholangitis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Cholecystitis acute  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Cholelithiasis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Cytolytic hepatitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Hepatic function abnormal  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Hepatitis toxic  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Hepatotoxicity  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Hyperbilirubinaemia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  5/1126 (0.44%)  3/1145 (0.26%)  1/1135 (0.09%) 
Hypersensitivity  1  3/1126 (0.27%)  1/1145 (0.09%)  1/1135 (0.09%) 
Anaphylactic reaction  1  0/1126 (0.00%)  3/1145 (0.26%)  0/1135 (0.00%) 
Anaphylactic shock  1  2/1126 (0.18%)  0/1145 (0.00%)  1/1135 (0.09%) 
Anaphylactiod reaction  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Infections and infestations       
Device related infection  1  8/1126 (0.71%)  12/1145 (1.05%)  4/1135 (0.35%) 
Pneumonia  1  3/1126 (0.27%)  4/1145 (0.35%)  5/1135 (0.44%) 
Urinary tract infection  1  2/1126 (0.18%)  5/1145 (0.44%)  4/1135 (0.35%) 
Sepsis  1  4/1126 (0.36%)  3/1145 (0.26%)  3/1135 (0.26%) 
Gastroenteritis  1  1/1126 (0.09%)  5/1145 (0.44%)  3/1135 (0.26%) 
Infection  1  5/1126 (0.44%)  3/1145 (0.26%)  1/1135 (0.09%) 
Abdominal abscess  1  2/1126 (0.18%)  4/1145 (0.35%)  2/1135 (0.18%) 
Catheter site infection  1  4/1126 (0.36%)  4/1145 (0.35%)  0/1135 (0.00%) 
Neutropenic sepsis  1  4/1126 (0.36%)  1/1145 (0.09%)  1/1135 (0.09%) 
Lower respiratory tract infection  1  3/1126 (0.27%)  2/1145 (0.17%)  0/1135 (0.00%) 
Anal abscess  1  0/1126 (0.00%)  3/1145 (0.26%)  1/1135 (0.09%) 
Cellulitis  1  3/1126 (0.27%)  0/1145 (0.00%)  1/1135 (0.09%) 
Abdominal wall abscess  1  0/1126 (0.00%)  2/1145 (0.17%)  1/1135 (0.09%) 
Device related sepsis  1  1/1126 (0.09%)  1/1145 (0.09%)  1/1135 (0.09%) 
Staphylococcal sepsis  1  1/1126 (0.09%)  0/1145 (0.00%)  2/1135 (0.18%) 
Abscess  1  0/1126 (0.00%)  2/1145 (0.17%)  0/1135 (0.00%) 
Erysipelas  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Herpes zoster  1  1/1126 (0.09%)  0/1145 (0.00%)  1/1135 (0.09%) 
Neutropenic infection  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pelvic abscess  1  0/1126 (0.00%)  2/1145 (0.17%)  0/1135 (0.00%) 
Septic shock  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Upper respiratory tract infection  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Viral infection  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Abdominal infection  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Appendicitis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Appendicitis perforated  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Aspergillosis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Bacteraemia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Bronchopneumonia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Bronchopulmonary aspergillosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Campylobacter infection  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Candida sepsis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Catheter site cellulitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Cholecystitis infective  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Clostridial infection  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Clostridium difficile colitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Diverticulitis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Enteritis infection  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gastroenteritis norovirus  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gastroenteritis viral  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Hepatitis viral  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Herpes zoster ophthalmic  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Incision site cellulitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Intervertebral discitis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Intestinal fistual infection  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Klebsiella bacteraemia  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Klebsiella infection  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Lower respiratory tract infection viral  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Oral candidiasis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Orchitis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Overgrowth bacterial  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Perineal abscess  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pharyngitis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Post procedural infection  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Postoperative abscess  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Psoas abscess  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Puncture site infection  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Respiratory tract infection  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Skin infection  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Staphylococcal bacteraemia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Subcutaneous abscess  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Tooth abscess  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Tuberculosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Wound abscess  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Wound infection  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Injury, poisoning and procedural complications       
Incisional hernia  1  1/1126 (0.09%)  2/1145 (0.17%)  2/1135 (0.18%) 
Procedural site reaction  1  0/1126 (0.00%)  0/1145 (0.00%)  2/1135 (0.18%) 
Accident at work  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Anastomotic stenosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Brachial plexus injury  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Cervical vertebral fracture  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Drug toxicity  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Fall  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Foot fracture  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Femur fracture  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Head injury  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Joint dislocation  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Multiple fractures  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Post procedural fistula  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Post procedural haemorrhage  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Road traffic accident  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Subdural haematoma  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Thoracic vertebral fracture  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Tibia fracture  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Investigations       
Blood lactate dehydrogenase increased  1  1/1126 (0.09%)  0/1145 (0.00%)  1/1135 (0.09%) 
Blood creatinine increased  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Blood glucose fluctuation  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Weight increased  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  7/1126 (0.62%)  10/1145 (0.87%)  17/1135 (1.50%) 
Hyperglycaemia  1  3/1126 (0.27%)  4/1145 (0.35%)  2/1135 (0.18%) 
Hypokalaemia  1  2/1126 (0.18%)  3/1145 (0.26%)  2/1135 (0.18%) 
Decreased appetite  1  0/1126 (0.00%)  1/1145 (0.09%)  2/1135 (0.18%) 
Hypertriglyceridaemia  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Hypocalcaemia  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Hyponatraemia  1  0/1126 (0.00%)  2/1145 (0.17%)  0/1135 (0.00%) 
Diabetes mellitus  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Diabetic ketoacidosis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Gout  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Hypercholesterolaemia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Hypomagnesaemia  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  1/1126 (0.09%)  1/1145 (0.09%)  1/1135 (0.09%) 
Intervertebral disc protusion  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Muscle spasms  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Muscular weakness  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Musculoskeletal chest pain  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Musculoskeletal disorder  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Myalgia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Pain in extremity  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  1/1126 (0.09%)  0/1145 (0.00%)  1/1135 (0.09%) 
Benign lung neoplasm  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Nervous system disorders       
Syncope  1  2/1126 (0.18%)  5/1145 (0.44%)  1/1135 (0.09%) 
Transient ischaemic attack  1  1/1126 (0.09%)  3/1145 (0.26%)  2/1135 (0.18%) 
Cerebrovascular accident  1  0/1126 (0.00%)  2/1145 (0.17%)  1/1135 (0.09%) 
Neuropathy peripheral  1  1/1126 (0.09%)  1/1145 (0.09%)  1/1135 (0.09%) 
Convulsion  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Dizziness  1  2/1126 (0.18%)  0/1145 (0.00%)  0/1135 (0.00%) 
Epilepsy  1  0/1126 (0.00%)  0/1145 (0.00%)  2/1135 (0.18%) 
Headache  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Ischaemic stroke  1  0/1126 (0.00%)  0/1145 (0.00%)  2/1135 (0.18%) 
Peripheral sensory neuropathy  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Cerebral ischaemia  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Dysaesthesia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Encephalopathy  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Leukoaraiosis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Loss of consciousness  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Migraine  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Monoparesis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Neurotoxicity  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Orthostatic intolerance  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Paraesthesia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Post herpetic neuralgia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Reversible ischaemic neurological deficit  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Reversible posterior leukoencephalopathy syndrome  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Sensory disturbance  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Somnolence  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Speech disorder  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Psychiatric disorders       
Depression  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Alcoholism  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Anxiety  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Renal and urinary disorders       
Hydronephrosis  1  1/1126 (0.09%)  1/1145 (0.09%)  1/1135 (0.09%) 
Renal failure acute  1  2/1126 (0.18%)  1/1145 (0.09%)  0/1135 (0.00%) 
Renal failure  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Renal impairment  1  0/1126 (0.00%)  1/1145 (0.09%)  1/1135 (0.09%) 
Ureteric stenosis  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Acute prerenal failure  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Calculus ureteric  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Calculus urinary  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Nephrogenic diabetes insipidus  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Nephrotic syndrome  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Reproductive system and breast disorders       
Female genital tract fistula  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Prostatitis  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Vaginal haemorrhage  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  11/1126 (0.98%)  15/1145 (1.31%)  10/1135 (0.88%) 
Dyspnoea  1  2/1126 (0.18%)  3/1145 (0.26%)  2/1135 (0.18%) 
Epistaxis  1  0/1126 (0.00%)  3/1145 (0.26%)  1/1135 (0.09%) 
Bronchospasm  1  0/1126 (0.00%)  1/1145 (0.09%)  2/1135 (0.18%) 
Dysaesthesia pharynx  1  0/1126 (0.00%)  0/1145 (0.00%)  3/1135 (0.26%) 
Laryngospasm  1  0/1126 (0.00%)  0/1145 (0.00%)  3/1135 (0.26%) 
Pneumothorax  1  1/1126 (0.09%)  2/1145 (0.17%)  0/1135 (0.00%) 
Respiratory failure  1  0/1126 (0.00%)  0/1145 (0.00%)  2/1135 (0.18%) 
Acute respiratory distress syndrome  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Interstitial lung disease  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Organising pneumonia  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pneumonia aspiration  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Pulmonary artery thrombosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pulmonary oedema  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Drug eruption  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Palmar-Plantar  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Swelling face  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Urticaria  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Social circumstances       
Pregnancy of partner  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Surgical and medical procedures       
Central venous catheter removal  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Vascular disorders       
Deep vein thrombosis  1  9/1126 (0.80%)  16/1145 (1.40%)  12/1135 (1.06%) 
Hypertension  1  1/1126 (0.09%)  2/1145 (0.17%)  13/1135 (1.15%) 
Venous thrombosis  1  3/1126 (0.27%)  5/1145 (0.44%)  1/1135 (0.09%) 
Jugular vein thrombosis  1  2/1126 (0.18%)  3/1145 (0.26%)  0/1135 (0.00%) 
Subclavian vein thrombosis  1  1/1126 (0.09%)  2/1145 (0.17%)  2/1135 (0.18%) 
Venous thrombosis limb  1  0/1126 (0.00%)  3/1145 (0.26%)  2/1135 (0.18%) 
Hypertensive crisis  1  0/1126 (0.00%)  3/1145 (0.26%)  1/1135 (0.09%) 
Hypotension  1  0/1126 (0.00%)  2/1145 (0.17%)  1/1135 (0.09%) 
Thrombophlebitis  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Thrombosis  1  1/1126 (0.09%)  1/1145 (0.09%)  0/1135 (0.00%) 
Arterial stenosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Arterial thrombosis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Arterial thrombosis limb  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Axillary vein thrombosis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Pelvic venous thrombosis  1  0/1126 (0.00%)  0/1145 (0.00%)  1/1135 (0.09%) 
Peripheral ischaemia  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Phlebitis  1  0/1126 (0.00%)  1/1145 (0.09%)  0/1135 (0.00%) 
Thrombophlebitis superficial  1  1/1126 (0.09%)  0/1145 (0.00%)  0/1135 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFOX4 FOLFOX4 + Bv XELOX+Bv
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1112/1126 (98.76%)   1127/1145 (98.43%)   1117/1135 (98.41%) 
Blood and lymphatic system disorders       
Neutropenia  1  660/1126 (58.61%)  567/1145 (49.52%)  273/1135 (24.05%) 
Thrombocytopenia  1  331/1126 (29.40%)  115/1145 (10.04%)  99/1135 (8.72%) 
Anaemia  1  116/1126 (10.30%)  89/1145 (7.77%)  74/1135 (6.52%) 
Leukopenia  1  79/1126 (7.02%)  55/1145 (4.80%)  34/1135 (3.00%) 
Eye disorders       
Lacrimation increased  1  70/1126 (6.22%)  69/1145 (6.03%)  35/1135 (3.08%) 
Gastrointestinal disorders       
Nausea  1  725/1126 (64.39%)  761/1145 (66.46%)  720/1135 (63.44%) 
Diarrhoea  1  620/1126 (55.06%)  699/1145 (61.05%)  699/1135 (61.59%) 
Vomiting  1  385/1126 (34.19%)  394/1145 (34.41%)  460/1135 (40.53%) 
Stomatitis  1  310/1126 (27.53%)  360/1145 (31.44%)  246/1135 (21.67%) 
Constipation  1  308/1126 (27.35%)  324/1145 (28.30%)  219/1135 (19.30%) 
Abdominal pain  1  220/1126 (19.54%)  227/1145 (19.83%)  214/1135 (18.85%) 
Dyspepsia  1  126/1126 (11.19%)  162/1145 (14.15%)  84/1135 (7.40%) 
Abdominal pain upper  1  86/1126 (7.64%)  118/1145 (10.31%)  113/1135 (9.96%) 
Haemorrhoids  1  29/1126 (2.58%)  68/1145 (5.94%)  41/1135 (3.61%) 
General disorders       
Fatigue  1  404/1126 (35.88%)  425/1145 (37.12%)  355/1135 (31.28%) 
Asthenia  1  241/1126 (21.40%)  251/1145 (21.92%)  250/1135 (22.03%) 
Pyrexia  1  186/1126 (16.52%)  185/1145 (16.16%)  106/1135 (9.34%) 
Mucosal inflammation  1  85/1126 (7.55%)  85/1145 (7.42%)  57/1135 (5.02%) 
Temperature intolerance  1  61/1126 (5.42%)  61/1145 (5.33%)  50/1135 (4.41%) 
Oedema peripheral  1  54/1126 (4.80%)  62/1145 (5.41%)  45/1135 (3.96%) 
Immune system disorders       
Drug hypersensitivity  1  66/1126 (5.86%)  72/1145 (6.29%)  32/1135 (2.82%) 
Infections and infestations       
Nasopharyngitis  1  76/1126 (6.75%)  92/1145 (8.03%)  70/1135 (6.17%) 
Upper respiratory tract infection  1  52/1126 (4.62%)  87/1145 (7.60%)  55/1135 (4.85%) 
Investigations       
Weight increased  1  58/1126 (5.15%)  81/1145 (7.07%)  68/1135 (5.99%) 
Weight decreased  1  26/1126 (2.31%)  56/1145 (4.89%)  61/1135 (5.37%) 
Metabolism and nutrition disorders       
Decreased appetite  1  268/1126 (23.80%)  324/1145 (28.30%)  295/1135 (25.99%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  63/1126 (5.60%)  140/1145 (12.23%)  122/1135 (10.75%) 
Pain in extremity  1  63/1126 (5.60%)  78/1145 (6.81%)  116/1135 (10.22%) 
Back pain  1  79/1126 (7.02%)  87/1145 (7.60%)  66/1135 (5.81%) 
Musculoskeletal pain  1  35/1126 (3.11%)  86/1145 (7.51%)  46/1135 (4.05%) 
Myalgia  1  39/1126 (3.46%)  70/1145 (6.11%)  56/1135 (4.93%) 
Nervous system disorders       
Peripheral sensory neuropathy  1  430/1126 (38.19%)  430/1145 (37.55%)  436/1135 (38.41%) 
Paraesthesia  1  310/1126 (27.53%)  328/1145 (28.65%)  314/1135 (27.67%) 
Neuropathy peripheral  1  252/1126 (22.38%)  234/1145 (20.44%)  204/1135 (17.97%) 
Headache  1  169/1126 (15.01%)  284/1145 (24.80%)  219/1135 (19.30%) 
Dysgeusia  1  237/1126 (21.05%)  222/1145 (19.39%)  152/1135 (13.39%) 
Dysaesthesia  1  128/1126 (11.37%)  106/1145 (9.26%)  128/1135 (11.28%) 
Dizziness  1  102/1126 (9.06%)  117/1145 (10.22%)  79/1135 (6.96%) 
Neurotoxicity  1  60/1126 (5.33%)  69/1145 (6.03%)  50/1135 (4.41%) 
Lethargy  1  44/1126 (3.91%)  50/1145 (4.37%)  59/1135 (5.20%) 
Psychiatric disorders       
Insomnia  1  135/1126 (11.99%)  132/1145 (11.53%)  91/1135 (8.02%) 
Anxiety  1  45/1126 (4.00%)  60/1145 (5.24%)  61/1135 (5.37%) 
Renal and urinary disorders       
Proteinuria  1  19/1126 (1.69%)  73/1145 (6.38%)  69/1135 (6.08%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  228/1126 (20.25%)  424/1145 (37.03%)  216/1135 (19.03%) 
Cough  1  86/1126 (7.64%)  120/1145 (10.48%)  41/1135 (3.61%) 
Dyspnoea  1  57/1126 (5.06%)  74/1145 (6.46%)  73/1135 (6.43%) 
Dysphonia  1  17/1126 (1.51%)  91/1145 (7.95%)  74/1135 (6.52%) 
Dysaesthesia pharynx  1  37/1126 (3.29%)  28/1145 (2.45%)  79/1135 (6.96%) 
Oropharyngeal pain  1  52/1126 (4.62%)  59/1145 (5.15%)  33/1135 (2.91%) 
Skin and subcutaneous tissue disorders       
Palmar-Plantar Erythrodysaesthesia Syndrome  1  98/1126 (8.70%)  119/1145 (10.39%)  435/1135 (38.33%) 
Alopecia  1  231/1126 (20.52%)  241/1145 (21.05%)  73/1135 (6.43%) 
Rash  1  114/1126 (10.12%)  112/1145 (9.78%)  110/1135 (9.69%) 
Dry skin  1  52/1126 (4.62%)  66/1145 (5.76%)  50/1135 (4.41%) 
Pruritus  1  36/1126 (3.20%)  65/1145 (5.68%)  28/1135 (2.47%) 
Vascular disorders       
Hypertension  1  196/1126 (17.41%)  472/1145 (41.22%)  468/1135 (41.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00112918     History of Changes
Other Study ID Numbers: CDR0000427299
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-0412086-01
ROCHE-BO17920A
First Submitted: June 2, 2005
First Posted: June 3, 2005
Results First Submitted: June 1, 2012
Results First Posted: September 6, 2012
Last Update Posted: August 27, 2013