Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab. (NCT NCT00439517)
NCT ID: NCT00439517
Last Updated: 2014-06-27
Results Overview
Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
302 participants
Primary outcome timeframe
Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
Results posted on
2014-06-27
Participant Flow
First subject randomised 12 February 2007, last subject randomised 30 June 2008. Cut off date was 30th June 2009
A total of 329 participants were screened and 302 participants were included in the Intent to Treat (ITT) Population. One patient included in the ITT population received no study medication and was not included in the Safety Population which comprised 301 participants (151 received UFOX plus cetuximab and 150 FOLFOX4 plus cetuximab).
Participant milestones
| Measure |
UFOX + Cetuximab
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
150
|
|
Overall Study
COMPLETED
|
150
|
150
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
UFOX + Cetuximab
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Overall Study
Subject on treatment
|
1
|
0
|
|
Overall Study
Subject in survival follow-up
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.
Baseline characteristics by cohort
| Measure |
UFOX + Cetuximab
n=152 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
61 years
STANDARD_DEVIATION 11.04 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
|
Age, Customized
<65 years
|
93 participants
n=5 Participants
|
84 participants
n=7 Participants
|
177 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
57 participants
n=5 Participants
|
66 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Age, Customized
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
28 participants
n=5 Participants
|
33 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009Population: Intention-to-treat (ITT) population i.e. all randomized subjects .
Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
Outcome measures
| Measure |
UFOX + Cetuximab
n=152 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Progression-free Survival (PFS)
|
6.6 months
Interval 5.6 to 7.2
|
8.2 months
Interval 7.5 to 9.2
|
SECONDARY outcome
Timeframe: Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009Population: ITT population i.e. all randomized subjects.
BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as "Disappearance of all target lesions plus disappearance of all non-target lesions \& without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as "At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later
Outcome measures
| Measure |
UFOX + Cetuximab
n=152 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Best Overall Response (BOR)
|
37.5 percentage of participants
Interval 29.8 to 45.7
|
51.3 percentage of participants
Interval 43.0 to 59.6
|
SECONDARY outcome
Timeframe: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009Population: ITT population i.e. all randomized subjects.
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome measures
| Measure |
UFOX + Cetuximab
n=152 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Overall Survival (OS)
|
12.9 months
Interval 11.5 to 15.8
|
15.5 months
Interval 12.6 to 18.1
|
SECONDARY outcome
Timeframe: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011Population: ITT population i.e. all randomized subjects.
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome measures
| Measure |
UFOX + Cetuximab
n=152 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Overall Survival (OS)
|
16.8 months
Interval 13.9 to 18.5
|
18.4 months
Interval 15.3 to 20.9
|
SECONDARY outcome
Timeframe: At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delaysPopulation: Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population
All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0="Not at all" to 4="Very much". For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.
Outcome measures
| Measure |
UFOX + Cetuximab
n=137 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=132 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Baseline
|
98.22 scores on a scale
Standard Error 1.725
|
96.45 scores on a scale
Standard Error 1.749
|
|
Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Cycle 3
|
95.41 scores on a scale
Standard Error 1.735
|
95.89 scores on a scale
Standard Error 1.806
|
|
Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Cycle 6
|
94.75 scores on a scale
Standard Error 2.090
|
94.70 scores on a scale
Standard Error 2.126
|
SECONDARY outcome
Timeframe: at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delaysPopulation: Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.
The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.
Outcome measures
| Measure |
UFOX + Cetuximab
n=136 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=130 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
Baseline
|
0.747 scores on a scale
Standard Error 0.021
|
0.734 scores on a scale
Standard Error 0.021
|
|
QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
Cycle 3
|
0.782 scores on a scale
Standard Error 0.021
|
0.758 scores on a scale
Standard Error 0.022
|
|
QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
Cycle 6
|
0.758 scores on a scale
Standard Error 0.026
|
0.771 scores on a scale
Standard Error 0.026
|
SECONDARY outcome
Timeframe: at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delaysPopulation: Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population. The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles
TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.
Outcome measures
| Measure |
UFOX + Cetuximab
n=99 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=99 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
QOL Therapy Preference Questionnaire (TPQ)
Baseline: Does not increase your risk of infection
|
18 percentage of participants
|
16 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Baseline: Does not interfere with daily activities
|
17 percentage of participants
|
15 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Baseline: Does not make you vomit
|
4 percentage of participants
|
14 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Baseline: Does not give you diarrhea
|
9 percentage of participants
|
5 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Cycle 3: Does not increase your risk of infection
|
15 percentage of participants
|
15 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Cycle 3: Does not interfere with daily activities
|
10 percentage of participants
|
11 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Cycle 3: Does not make you vomit
|
4 percentage of participants
|
10 percentage of participants
|
|
QOL Therapy Preference Questionnaire (TPQ)
Cycle 3: Does not give you diarrhea
|
15 percentage of participants
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009Population: ITT population
Non-protocol medical care visits and consultations
Outcome measures
| Measure |
UFOX + Cetuximab
n=152 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Emergency room visit
|
34 visits or consultations
|
26 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Hospital oupatient clinic visit
|
40 visits or consultations
|
35 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Practice visit
|
71 visits or consultations
|
159 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Home visit
|
15 visits or consultations
|
130 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
General Practitioner consultation
|
65 visits or consultations
|
124 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Specialist consultation
|
62 visits or consultations
|
84 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Nurse consultation
|
15 visits or consultations
|
123 visits or consultations
|
|
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Other consultation
|
19 visits or consultations
|
18 visits or consultations
|
SECONDARY outcome
Timeframe: Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009Population: Safety population
Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
Outcome measures
| Measure |
UFOX + Cetuximab
n=151 Participants
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 Participants
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Safety - Number of Patients Experiencing Any Adverse Event
|
151 participants
|
149 participants
|
Adverse Events
UFOX + Cetuximab
Serious events: 52 serious events
Other events: 151 other events
Deaths: 0 deaths
FOLFOX4 + Cetuximab
Serious events: 48 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UFOX + Cetuximab
n=151 participants at risk
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 participants at risk
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Vascular disorders
Femoral artery embolism
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
2.7%
4/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Anal fistula
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Colitis
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
13/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
2.7%
4/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Ileus
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Nausea
|
2.6%
4/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Proctalgia
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Subileus
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
9/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
2.0%
3/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Asthenia
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Chills
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Fatigue
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
General physical health deterioration
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
2.7%
4/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Inflammation
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Pyrexia
|
2.0%
3/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Hepatobiliary disorders
Biliary colic
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Hepatobiliary disorders
Hepatic failure
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Anal abscess
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Cellulitis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Central line infection
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
3.3%
5/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Hepatitis C
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Pneumonia
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Pyelonephritis acute
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Rectal abscess
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Septic shock
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Urosepsis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Injury, poisoning and procedural complications
Overdose
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Anorexia
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
2/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Coma hepatic
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Grand mal convulsion
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Headache
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Syncope
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Psychiatric disorders
Confusional state
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Renal and urinary disorders
Hydronephrosis
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Renal and urinary disorders
Renal failure acute
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Renal and urinary disorders
Ureteric perforation
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Renal and urinary disorders
Urethral disorder
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.00%
0/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
1/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
1.3%
2/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
Other adverse events
| Measure |
UFOX + Cetuximab
n=151 participants at risk
UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
|
FOLFOX4 + Cetuximab
n=150 participants at risk
FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
43.3%
65/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.9%
33/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
24.7%
37/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
18.7%
28/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Blood and lymphatic system disorders
Anaemia
|
9.9%
15/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
17.3%
26/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Eye disorders
Conjunctivitis
|
9.3%
14/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
9.3%
14/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Diarrhoea
|
52.3%
79/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
48.0%
72/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Nausea
|
44.4%
67/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
36.7%
55/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Stomatitis
|
9.9%
15/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
24.0%
36/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
40/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
21.3%
32/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Constipation
|
19.2%
29/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
20.0%
30/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Abdominal pain
|
22.5%
34/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
16.7%
25/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
9/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
0.67%
1/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Fatigue
|
25.2%
38/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
25.3%
38/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Pyrexia
|
19.9%
30/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
24.0%
36/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Mucosal inflammation
|
9.9%
15/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
22.7%
34/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Asthenia
|
16.6%
25/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
18.0%
27/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Oedema peripheral
|
7.3%
11/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
7.3%
11/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
General disorders
Chills
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
6.0%
9/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.9%
12/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
4.0%
6/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Immune system disorders
Drug hypersensitivity
|
7.9%
12/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
6.7%
10/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Immune system disorders
Hypersensitivity
|
2.0%
3/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Paronychia
|
17.2%
26/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
22.0%
33/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Folliculitis
|
5.3%
8/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
9.3%
14/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
6/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
7.3%
11/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Infections and infestations
Pharyngitis
|
5.3%
8/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
4.7%
7/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Investigations
Weight decreased
|
7.9%
12/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
10.7%
16/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
9/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Investigations
Platelet count decreased
|
6.0%
9/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
4.0%
6/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
3.3%
5/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Anorexia
|
26.5%
40/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
24.0%
36/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.3%
17/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
10.0%
15/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.9%
15/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
9.3%
14/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
6.7%
10/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Paraesthesia
|
25.2%
38/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
28.7%
43/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.2%
29/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
18.0%
27/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Neuropathy peripheral
|
11.3%
17/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
14.7%
22/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Dysgeusia
|
8.6%
13/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
13.3%
20/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Polyneuropathy
|
4.0%
6/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
11.3%
17/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Headache
|
4.0%
6/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
6.7%
10/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Nervous system disorders
Dysaesthesia
|
7.3%
11/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
3.3%
5/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Psychiatric disorders
Insomnia
|
6.0%
9/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
3.3%
5/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
9/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
8.7%
13/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
5.3%
8/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
8/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
4.7%
7/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.7%
63/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
31.3%
47/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
26.5%
40/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
30.0%
45/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.9%
27/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
19.3%
29/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.6%
13/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
14.7%
22/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
8/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
10.0%
15/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Acne
|
13.2%
20/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
9.3%
14/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
8.7%
13/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
6/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
8.7%
13/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.6%
10/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
8.0%
12/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.6%
7/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
7.3%
11/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
5/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
6.0%
9/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
|
Vascular disorders
Hypertension
|
5.3%
8/151 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
7.3%
11/150 • Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER