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A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon 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: NCT00069121
Recruitment Status : Completed
First Posted : September 18, 2003
Results First Posted : July 29, 2011
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Capecitabine
Drug: Oxaliplatin
Drug: Leucovorin (LV)
Drug: 5-Fluorouracil (5-FU)
Enrollment 1886
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Period Title: Overall Study
Started 942 944
Received Treatment 926 [1] 938 [1]
Completed 575 [2] 619 [2]
Not Completed 367 325
Reason Not Completed
Death             286             242
Withdrawal by Subject             18             20
Lost to Follow-up             63             63
[1]
Safety Population
[2]
total includes Completed and Alive in follow-up
Arm/Group Title 5-FU/LV XELOX Total
Hide Arm/Group Description Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) Total of all reporting groups
Overall Number of Baseline Participants 942 944 1886
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 942 participants 944 participants 1886 participants
60.5  (10.76) 59.8  (10.95) 60.2  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 942 participants 944 participants 1886 participants
Female
442
  46.9%
431
  45.7%
873
  46.3%
Male
500
  53.1%
513
  54.3%
1013
  53.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 942 participants 944 participants 1886 participants
Female
442
  46.9%
431
  45.7%
873
  46.3%
Male
500
  53.1%
513
  54.3%
1013
  53.7%
1.Primary Outcome
Title Disease-Free Survival (DFS) [Number of Events]
Hide Description Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
Time Frame Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description:
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 942 944
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with Event
379
  40.2%
320
  33.9%
Patients without Events
563
  59.8%
624
  66.1%
2.Primary Outcome
Title Disease-Free Survival (DFS) [Time to Event]
Hide Description Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Time Frame Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description:
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 942 944
Median (Full Range)
Unit of Measure: months
NA [1] 
(0 to 95)
88.6
(0 to 89)
[1]
The median time for DFS was not reached in this adjuvant trial; however, due to a late event in the XELOX arm and an artificial drop in the Kaplan-Meier estimate, an artificial median estimate for the XELOX groups appears.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5-FU/LV, XELOX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments This test used a two-sided significance level of 5%.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.69 to 0.93
Estimation Comments The hazard ratio was calculated as XELOX versus 5-FU/LV arms.
3.Secondary Outcome
Title Relapse-Free Survival (RFS) [Number of Events]
Hide Description A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.
Time Frame Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description:
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 942 944
Measure Type: Count of Participants
Unit of Measure: Participants
Patients With Event
356
  37.8%
290
  30.7%
Patients Without Events
586
  62.2%
654
  69.3%
4.Secondary Outcome
Title Relapse-Free Survival (RFS) [Time to Event]
Hide Description A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Time Frame Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description:
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 942 944
Median (Full Range)
Unit of Measure: months
NA [1] 
(0 to 95)
88.6
(0 to 89)
[1]
The median time for RFS was not reached in this adjuvant trial; however, due to a late event in the XELOX arm and an artificial drop in the Kaplan-Meier estimate, an artificial median estimate for the XELOX groups appears.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5-FU/LV, XELOX
Comments [Not Specified]
Type of Statistical Test Other
Comments Descriptive analysis only.
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.67 to 0.91
Estimation Comments The hazard ratio was calculated as XELOX versus 5-FU/LV arms.
5.Secondary Outcome
Title Overall Survival [Number of Events]
Hide Description Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Time Frame Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description:
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 942 944
Measure Type: Count of Participants
Unit of Measure: Participants
Patients With Event
286
  30.4%
242
  25.6%
Patients Without Events
656
  69.6%
702
  74.4%
6.Secondary Outcome
Title Overall Survival [Time to Event]
Hide Description Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Time Frame Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
Arm/Group Title 5-FU/LV XELOX
Hide Arm/Group Description:
Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 942 944
Median (Full Range)
Unit of Measure: months
NA [1] 
(0 to 95)
NA [1] 
(0 to 93)
[1]
The median time to death was not reached in this adjuvant trial.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5-FU/LV, XELOX
Comments [Not Specified]
Type of Statistical Test Other
Comments Descriptive analysis only.
Statistical Test of Hypothesis P-Value 0.0367
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.70 to 0.99
Estimation Comments The hazard ratio was calculated as XELOX versus 5-FU/LV arms.
7.Secondary Outcome
Title Number of Participants With at Least One Adverse Event by Most Severe Intensity
Hide Description The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.
Time Frame From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received.
Arm/Group Title 5-FU/LV MAYO CLINIC 5-FU/LV ROSWELL PARK XELOX
Hide Arm/Group Description:
Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
Overall Number of Participants Analyzed 657 269 938
Measure Type: Count of Participants
Unit of Measure: Participants
Mild AEs
557
  84.8%
256
  95.2%
855
  91.2%
Moderate AEs
493
  75.0%
217
  80.7%
792
  84.4%
Severe AEs
299
  45.5%
146
  54.3%
548
  58.4%
Life-Threatening
83
  12.6%
21
   7.8%
63
   6.7%
Time Frame From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
Adverse Event Reporting Description AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938)
 
Arm/Group Title 5-FU/LV MAYO CLINIC 5-FU/LV ROSWELL PARK XELOX
Hide Arm/Group Description 5-fluorouracil/leucovorin 5-fluorouracil/leucovorin Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
All-Cause Mortality
5-FU/LV MAYO CLINIC 5-FU/LV ROSWELL PARK XELOX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   215/664 (32.38%)   71/278 (25.54%)   242/944 (25.64%) 
Hide Serious Adverse Events
5-FU/LV MAYO CLINIC 5-FU/LV ROSWELL PARK XELOX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   134/657 (20.40%)   88/269 (32.71%)   208/938 (22.17%) 
Blood and lymphatic system disorders       
FEBRILE NEUTROPENIA  1  31/657 (4.72%)  2/269 (0.74%)  2/938 (0.21%) 
NEUTROPENIA  1  8/657 (1.22%)  2/269 (0.74%)  3/938 (0.32%) 
ANAEMIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
COAGULOPATHY  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
HAEMOLYTIC URAEMIC SYNDROME  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
LEUKOPENIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
THROMBOCYTOPENIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  3/657 (0.46%)  1/269 (0.37%)  5/938 (0.53%) 
ACUTE MYOCARDIAL INFARCTION  1  0/657 (0.00%)  0/269 (0.00%)  3/938 (0.32%) 
ANGINA PECTORIS  1  2/657 (0.30%)  0/269 (0.00%)  1/938 (0.11%) 
MYOCARDIAL INFARCTION  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
ANGINA UNSTABLE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ARRHYTHMIA SUPRAVENTRICULAR  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CARDIAC ARREST  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
MYOCARDIAL ISCHAEMIA  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
PERICARDIAL EFFUSION  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
TACHYCARDIA  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Ear and labyrinth disorders       
VERTIGO POSITIONAL  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Eye disorders       
EYE MOVEMENT DISORDER  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Gastrointestinal disorders       
DIARRHOEA  1  39/657 (5.94%)  24/269 (8.92%)  55/938 (5.86%) 
STOMATITIS ALL  1  22/657 (3.35%)  0/269 (0.00%)  2/938 (0.21%) 
VOMITING  1  6/657 (0.91%)  3/269 (1.12%)  15/938 (1.60%) 
ABDOMINAL PAIN  1  5/657 (0.76%)  3/269 (1.12%)  13/938 (1.39%) 
INTESTINAL OBSTRUCTION  1  5/657 (0.76%)  2/269 (0.74%)  7/938 (0.75%) 
SMALL INTESTINAL OBSTRUCTION  1  1/657 (0.15%)  3/269 (1.12%)  8/938 (0.85%) 
ILEUS  1  2/657 (0.30%)  4/269 (1.49%)  3/938 (0.32%) 
NAUSEA  1  3/657 (0.46%)  1/269 (0.37%)  4/938 (0.43%) 
COLITIS  1  1/657 (0.15%)  1/269 (0.37%)  3/938 (0.32%) 
ENTERITIS  1  2/657 (0.30%)  2/269 (0.74%)  1/938 (0.11%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/657 (0.00%)  0/269 (0.00%)  4/938 (0.43%) 
SUBILEUS  1  1/657 (0.15%)  0/269 (0.00%)  3/938 (0.32%) 
ABDOMINAL ADHESIONS  1  0/657 (0.00%)  1/269 (0.37%)  1/938 (0.11%) 
ENTEROCOLITIS  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
GASTRIC HAEMORRHAGE  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
GASTRITIS  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
GASTROINTESTINAL TOXICITY  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
HAEMATEMESIS  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
ILEITIS  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
INTESTINAL ISCHAEMIA  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
LARGE INTESTINAL OBSTRUCTION  1  1/657 (0.15%)  1/269 (0.37%)  0/938 (0.00%) 
NEUTROPENIC COLITIS  1  1/657 (0.15%)  1/269 (0.37%)  0/938 (0.00%) 
ABDOMINAL MASS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ASCITES  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
CAECITIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
COLITIS ISCHAEMIC  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
COLONIC FISTULA  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
CONSTIPATION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CROHN’S DISEASE  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
GASTRITIS EROSIVE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
GASTROINTESTINAL OBSTRUCTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
GASTROINTESTINAL OEDEMA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
GASTROINTESTINAL ULCER  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ILEUS PARALYTIC  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
INTERNAL HERNIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
INTESTINAL PERFORATION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
MECHANICAL ILEUS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
OESOPHAGEAL MASS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PERITONITIS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
PNEUMATOSIS INTESTINALIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
SMALL INTESTINAL PERFORATION  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
General disorders       
PYREXIA  1  2/657 (0.30%)  3/269 (1.12%)  12/938 (1.28%) 
CHEST PAIN  1  0/657 (0.00%)  1/269 (0.37%)  2/938 (0.21%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
CHEST DISCOMFORT  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CHILLS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
DISEASE PROGRESSION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
FATIGUE  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
OEDEMA PERIPHERAL  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Hepatobiliary disorders       
CHOLELITHIASIS  1  0/657 (0.00%)  3/269 (1.12%)  0/938 (0.00%) 
CHOLECYSTITIS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
CHOLECYSTITIS ACUTE  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
HEPATIC LESION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PORTAL VEIN THROMBOSIS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Immune system disorders       
HYPERSENSITIVITY  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
ANAPHYLACTIC REACTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ANAPHYLACTOID REACTION  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
Infections and infestations       
PNEUMONIA  1  2/657 (0.30%)  1/269 (0.37%)  5/938 (0.53%) 
SEPSIS  1  3/657 (0.46%)  1/269 (0.37%)  3/938 (0.32%) 
NEUTROPENIC SEPSIS  1  5/657 (0.76%)  0/269 (0.00%)  0/938 (0.00%) 
GASTROENTERITIS  1  1/657 (0.15%)  2/269 (0.74%)  1/938 (0.11%) 
BACTERAEMIA  1  0/657 (0.00%)  0/269 (0.00%)  3/938 (0.32%) 
CLOSTRIDIAL INFECTION  1  1/657 (0.15%)  1/269 (0.37%)  1/938 (0.11%) 
ANAL ABSCESS  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
INFECTION  1  0/657 (0.00%)  1/269 (0.37%)  1/938 (0.11%) 
SEPTIC SHOCK  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
ABDOMINAL ABSCESS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ABDOMINAL WALL ABSCESS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
BRONCHITIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
BRONCHOPNEUMONIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CELLULITIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
DIVERTICULITIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ENDOPHTHALMITIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
HEPATITIS B  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ORAL CANDIDIASIS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
PHARYNGITIS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
POSTOPERATIVE WOUND INFECTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
RESPIRATORY TRACT INFECTION  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
SEPSIS SYNDROME  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
SKIN INFECTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
STAPHYLOCOCCAL INFECTION  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
URINARY TRACT INFECTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
VIRAL INFECTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Injury, poisoning and procedural complications       
FEMUR FRACTURE  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
ACCIDENTAL OVERDOSE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
INCISIONAL HERNIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PROCEDURAL SITE REACTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
SUBDURAL HAEMATOMA  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
UPPER LIMB FRACTURE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
WOUND DEHISCENCE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Investigations       
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
BLOOD BILIRUBIN ABNORMAL  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CULTURE STOOL POSITIVE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Metabolism and nutrition disorders       
DEHYDRATION  1  4/657 (0.61%)  10/269 (3.72%)  24/938 (2.56%) 
HYPOKALAEMIA  1  0/657 (0.00%)  0/269 (0.00%)  3/938 (0.32%) 
ANOREXIA  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
HYPERGLYCAEMIA  1  0/657 (0.00%)  1/269 (0.37%)  1/938 (0.11%) 
ACIDOSIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
DIABETIC KETOACIDOSIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
FLUID OVERLOAD  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
HYPONATRAEMIA  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Musculoskeletal and connective tissue disorders       
ARTHRITIS  1  1/657 (0.15%)  1/269 (0.37%)  0/938 (0.00%) 
INTERVERTEBRAL DISC DISPLACEMENT  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
MYOSITIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
COLON CANCER  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Nervous system disorders       
SYNCOPE  1  2/657 (0.30%)  1/269 (0.37%)  1/938 (0.11%) 
LOSS OF CONSCIOUSNESS  1  0/657 (0.00%)  0/269 (0.00%)  3/938 (0.32%) 
DIZZINESS  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
CEREBRAL AMYLOID ANGIOPATHY  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CEREBROVASCULAR ACCIDENT  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ENCEPHALOPATHY  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
HAEMORRHAGIC CEREBRAL INFARCTION  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
HEADACHE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
HEMIPLEGIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
ISCHAEMIC STROKE  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
NERVOUS SYSTEM DISORDER  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
NEUROPATHY PERIPHERAL  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PARAESTHESIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PERIPHERAL MOTOR NEUROPATHY  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PERIPHERAL SENSORY NEUROPATHY  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
SCIATICA  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
SUPERIOR SAGITTAL SINUS THROMBOSIS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Psychiatric disorders       
PSYCHOTIC DISORDER  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Renal and urinary disorders       
RENAL FAILURE  1  2/657 (0.30%)  0/269 (0.00%)  3/938 (0.32%) 
HAEMATURIA  1  1/657 (0.15%)  1/269 (0.37%)  1/938 (0.11%) 
RENAL COLIC  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
RENAL FAILURE ACUTE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
URINARY RETENTION  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
UROGENITAL HAEMORRHAGE  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
Reproductive system and breast disorders       
MENORRHAGIA  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
OVARIAN MASS  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
VAGINAL HAEMORRHAGE  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
PULMONARY EMBOLISM  1  4/657 (0.61%)  5/269 (1.86%)  3/938 (0.32%) 
DYSPNOEA  1  0/657 (0.00%)  0/269 (0.00%)  3/938 (0.32%) 
DYSAESTHESIA PHARYNX  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
ASTHMA  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
BRONCHOSPASM  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
EPISTAXIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
HAEMOPTYSIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
LARYNGOSPASM  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PNEUMONIA ASPIRATION  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
PNEUMOTHORAX  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
PULMONARY OEDEMA  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
Skin and subcutaneous tissue disorders       
DERMATITIS CONTACT  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
RASH  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
Vascular disorders       
DEEP VEIN THROMBOSIS  1  3/657 (0.46%)  3/269 (1.12%)  5/938 (0.53%) 
HYPOTENSION  1  0/657 (0.00%)  1/269 (0.37%)  2/938 (0.21%) 
THROMBOSIS  1  1/657 (0.15%)  1/269 (0.37%)  1/938 (0.11%) 
HYPERTENSION  1  0/657 (0.00%)  0/269 (0.00%)  2/938 (0.21%) 
THROMBOPHLEBITIS  1  1/657 (0.15%)  0/269 (0.00%)  1/938 (0.11%) 
ARTERIAL OCCLUSIVE DISEASE  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
HYPOVOLAEMIC SHOCK  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
JUGULAR VEIN THROMBOSIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
NECROSIS OF ARTERY  1  1/657 (0.15%)  0/269 (0.00%)  0/938 (0.00%) 
SUBCLAVIAN VEIN THROMBOSIS  1  0/657 (0.00%)  1/269 (0.37%)  0/938 (0.00%) 
VENA CAVA THROMBOSIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
VENOUS THROMBOSIS  1  0/657 (0.00%)  0/269 (0.00%)  1/938 (0.11%) 
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5-FU/LV MAYO CLINIC 5-FU/LV ROSWELL PARK XELOX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   622/657 (94.67%)   262/269 (97.40%)   926/938 (98.72%) 
Blood and lymphatic system disorders       
NEUTROPENIA  1  232/657 (35.31%)  36/269 (13.38%)  260/938 (27.72%) 
THROMBOCYTOPENIA  1  2/657 (0.30%)  4/269 (1.49%)  167/938 (17.80%) 
ANAEMIA  1  32/657 (4.87%)  36/269 (13.38%)  64/938 (6.82%) 
FEBRILE NEUTROPENIA  1  36/657 (5.48%)  3/269 (1.12%)  4/938 (0.43%) 
Eye disorders       
LACRIMATION INCREASED  1  53/657 (8.07%)  49/269 (18.22%)  45/938 (4.80%) 
Gastrointestinal disorders       
DIARRHOEA  1  449/657 (68.34%)  219/269 (81.41%)  577/938 (61.51%) 
NAUSEA  1  350/657 (53.27%)  190/269 (70.63%)  625/938 (66.63%) 
STOMATITIS ALL  1  419/657 (63.77%)  57/269 (21.19%)  195/938 (20.79%) 
VOMITING  1  142/657 (21.61%)  103/269 (38.29%)  415/938 (44.24%) 
ABDOMINAL PAIN  1  118/657 (17.96%)  92/269 (34.20%)  204/938 (21.75%) 
CONSTIPATION  1  82/657 (12.48%)  48/269 (17.84%)  187/938 (19.94%) 
DYSPEPSIA  1  38/657 (5.78%)  37/269 (13.75%)  87/938 (9.28%) 
ABDOMINAL PAIN UPPER  1  44/657 (6.70%)  21/269 (7.81%)  77/938 (8.21%) 
FLATULENCE  1  21/657 (3.20%)  29/269 (10.78%)  47/938 (5.01%) 
DRY MOUTH  1  23/657 (3.50%)  14/269 (5.20%)  26/938 (2.77%) 
General disorders       
FATIGUE  1  148/657 (22.53%)  170/269 (63.20%)  332/938 (35.39%) 
ASTHENIA  1  91/657 (13.85%)  44/269 (16.36%)  167/938 (17.80%) 
PYREXIA  1  60/657 (9.13%)  43/269 (15.99%)  108/938 (11.51%) 
TEMPERATURE INTOLERANCE  1  0/657 (0.00%)  1/269 (0.37%)  104/938 (11.09%) 
OEDEMA PERIPHERAL  1  22/657 (3.35%)  29/269 (10.78%)  51/938 (5.44%) 
CHILLS  1  9/657 (1.37%)  16/269 (5.95%)  29/938 (3.09%) 
Infections and infestations       
NASOPHARYNGITIS  1  20/657 (3.04%)  15/269 (5.58%)  32/938 (3.41%) 
UPPER RESPIRATORY TRACT INFECTION  1  13/657 (1.98%)  18/269 (6.69%)  29/938 (3.09%) 
URINARY TRACT INFECTION  1  14/657 (2.13%)  20/269 (7.43%)  22/938 (2.35%) 
Metabolism and nutrition disorders       
ANOREXIA  1  101/657 (15.37%)  77/269 (28.62%)  240/938 (25.59%) 
DEHYDRATION  1  24/657 (3.65%)  33/269 (12.27%)  68/938 (7.25%) 
HYPOKALAEMIA  1  20/657 (3.04%)  33/269 (12.27%)  58/938 (6.18%) 
DECREASED APPETITE  1  16/657 (2.44%)  15/269 (5.58%)  27/938 (2.88%) 
Musculoskeletal and connective tissue disorders       
PAIN IN EXTREMITY  1  17/657 (2.59%)  21/269 (7.81%)  117/938 (12.47%) 
ARTHRALGIA  1  22/657 (3.35%)  26/269 (9.67%)  41/938 (4.37%) 
BACK PAIN  1  14/657 (2.13%)  25/269 (9.29%)  46/938 (4.90%) 
PAIN IN JAW  1  1/657 (0.15%)  0/269 (0.00%)  55/938 (5.86%) 
Nervous system disorders       
PARAESTHESIA  1  16/657 (2.44%)  10/269 (3.72%)  339/938 (36.14%) 
NEUROPATHY PERIPHERAL  1  8/657 (1.22%)  12/269 (4.46%)  279/938 (29.74%) 
DYSGEUSIA  1  86/657 (13.09%)  40/269 (14.87%)  126/938 (13.43%) 
HEADACHE  1  46/657 (7.00%)  31/269 (11.52%)  103/938 (10.98%) 
DIZZINESS  1  34/657 (5.18%)  34/269 (12.64%)  99/938 (10.55%) 
PERIPHERAL SENSORY NEUROPATHY  1  4/657 (0.61%)  11/269 (4.09%)  152/938 (16.20%) 
DYSAESTHESIA  1  1/657 (0.15%)  1/269 (0.37%)  104/938 (11.09%) 
LETHARGY  1  46/657 (7.00%)  3/269 (1.12%)  52/938 (5.54%) 
HYPOAESTHESIA  1  2/657 (0.30%)  7/269 (2.60%)  59/938 (6.29%) 
Psychiatric disorders       
INSOMNIA  1  49/657 (7.46%)  38/269 (14.13%)  78/938 (8.32%) 
ANXIETY  1  22/657 (3.35%)  31/269 (11.52%)  49/938 (5.22%) 
DEPRESSION  1  14/657 (2.13%)  24/269 (8.92%)  35/938 (3.73%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  15/657 (2.28%)  35/269 (13.01%)  47/938 (5.01%) 
OROPHARYNGEAL PAIN  1  39/657 (5.94%)  20/269 (7.43%)  38/938 (4.05%) 
DYSPNOEA  1  15/657 (2.28%)  16/269 (5.95%)  63/938 (6.72%) 
EPISTAXIS  1  24/657 (3.65%)  30/269 (11.15%)  40/938 (4.26%) 
DYSAESTHESIA PHARYNX  1  0/657 (0.00%)  0/269 (0.00%)  93/938 (9.91%) 
RHINORRHOEA  1  16/657 (2.44%)  20/269 (7.43%)  24/938 (2.56%) 
Skin and subcutaneous tissue disorders       
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  56/657 (8.52%)  42/269 (15.61%)  278/938 (29.64%) 
ALOPECIA  1  159/657 (24.20%)  25/269 (9.29%)  40/938 (4.26%) 
RASH  1  65/657 (9.89%)  41/269 (15.24%)  84/938 (8.96%) 
DRY SKIN  1  41/657 (6.24%)  44/269 (16.36%)  45/938 (4.80%) 
PRURITUS  1  20/657 (3.04%)  17/269 (6.32%)  21/938 (2.24%) 
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069121    
Obsolete Identifiers: NCT00080691
Other Study ID Numbers: NO16968
First Submitted: September 15, 2003
First Posted: September 18, 2003
Results First Submitted: March 31, 2011
Results First Posted: July 29, 2011
Last Update Posted: March 6, 2020