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A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

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ClinicalTrials.gov Identifier: NCT00069121
Recruitment Status : Completed
First Posted : September 18, 2003
Results First Posted : July 29, 2011
Last Update Posted : August 22, 2013
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 [Xeloda]
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5 FU
Enrollment 1886
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5-FU/LV XELOX
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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 640 [2] 668 [2]
Not Completed 302 276
Reason Not Completed
Death             225             197
Withdrawal by Subject             20             22
Lost to Follow-up             57             57
[1]
Safety Population
[2]
total includes Completed and Alive in follow-up
Arm/Group Title 5-FU/LV XELOX Total
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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
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[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%
1.Primary Outcome
Title Disease-free Survival (DFS) [Number of Events]
Hide Description Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.
Time Frame Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.
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Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
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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: Number
Unit of Measure: participants
Patients with event 353 295
Patients without events 589 649
2.Primary Outcome
Title Disease-free Survival [Time to Event]
Hide Description Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. 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 event/date last known to be event free. Median observation time for DFS was approx 57 mos.
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Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
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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 (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
67.9 [2] 
(68 to NA)
[1]
The median time for DFS was not reached in this adjuvant trial.
[2]
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.
3.Secondary Outcome
Title Relapse-free Survival (RFS) [Number of Events]
Hide Description Included only 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.
Time Frame Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.
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Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
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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: Number
Unit of Measure: participants
Patients with event 340 278
Patients without events 602 666
4.Secondary Outcome
Title Relapse-free Survival (RFS) [Time to Event]
Hide Description Included only 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. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.
Time Frame Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.
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Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
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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 (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
67.9 [2] 
(68 to NA)
[1]
The median time for RFS was not reached in this adjuvant trial.
[2]
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 .
5.Secondary Outcome
Title Overall Survival [Number of Events]
Hide Description Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients 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 for was approx 59 mos.
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Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
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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: Number
Unit of Measure: participants
Patients with event 225 197
Patients without events 717 747
6.Secondary Outcome
Title Overall Survival [Time to Event]
Hide Description Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients 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 for was approx 59 mos.
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Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title 5-FU/LV XELOX
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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 (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to death was not reached in this adjuvant trial.
7.Secondary Outcome
Title Number of Participants Assesed for Adverse Events
Hide Description

Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.

See Adverse Events module for details.

Time Frame followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake
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Safety Population
Arm/Group Title 5-FU/LV MAYO CLINIC 5-FU/LV ROSWELL PARK XELOX
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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: Number
Unit of Measure: participants
657 269 938
Time Frame Adverse Event Onset between Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake
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   --/--   --/--   --/-- 
Show Serious Adverse Events 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%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events 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   618/657 (94.06%)   262/269 (97.40%)   932/938 (99.36%) 
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%) 
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%) 
Hepatobiliary disorders       
ASTHENIA  1  91/657 (13.85%)  44/269 (16.36%)  167/938 (17.80%) 
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%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069121     History of Changes
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: August 22, 2013