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Trial record 82 of 104 for:    colon cancer | ( Map: Nebraska, United States )

Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00101686
Recruitment Status : Completed
First Posted : January 13, 2005
Results First Posted : November 26, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Drug: Modified Bolus 5-FU/LV with Irinotecan
Drug: FOLFIRI + bevacizumab
Drug: miFL + bevacizumab
Drug: Infusional 5-FU/LV with Irinotecan
Drug: Oral Capecitabine with Irinotecan
Enrollment 547
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FOLFIRI + Celecoxib FOLFIRI + Placebo mIFL + Celecoxib mIFL + Placebo CapeIRI + Celecoxib CapeIRI + Placebo Bevacizumab + FOLFIRI + Celecoxib Bevacizumab + FOLFIRI + Placebo Bevacizumab + mIFL + Celecoxib Bevacizumab + mIFL + Placebo
Hide Arm/Group Description Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo Irinotecan plus capecitabine (CapeIRI) with celecoxib Irinotecan plus capecitabine (CapeIRI) with placebo Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
Period Title: Overall Study
Started 71 73 69 72 73 72 27 30 30 30
Received Treatment 70 67 67 70 71 70 27 29 30 29
Completed 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1]
Not Completed 71 73 69 72 73 72 27 30 30 30
Reason Not Completed
Progressive Disease             37             28             37             38             28             25             5             7             10             8
initiation other anti-cancer treatment             4             3             4             3             1             1             2             2             3             3
>3 week delay treatment due toxicity             6             2             1             2             7             3             2             1             3             0
unacceptable toxicity             3             9             10             6             16             10             4             2             1             4
Randomized but did not receive treament             1             6             2             2             2             2             0             1             0             1
intercurrent non-cancer related illness             0             0             2             0             1             3             1             0             1             1
Physician Decision             10             13             6             7             8             9             5             5             1             1
Other             1             4             1             6             2             12             1             5             3             3
Withdrawal by Subject             9             8             6             8             8             7             7             7             8             9
[1]
Patients treated until disease progression.
Arm/Group Title FOLFIRI + Celecoxib FOLFIRI + Placebo mIFL + Celecoxib mIFL + Placebo CapeIRI + Celecoxib CapeIRI + Placebo Bevacizumab + FOLFIRI + Celecoxib Bevacizumab + FOLFIRI + Placebo Bevacizumab + mIFL + Celecoxib Bevacizumab + mIFL + Placebo Total
Hide Arm/Group Description Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo Irinotecan plus capecitabine (CapeIRI) with celecoxib Irinotecan plus capecitabine (CapeIRI) with placebo Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo Total of all reporting groups
Overall Number of Baseline Participants 71 73 69 72 73 72 27 30 30 30 547
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 71 participants 73 participants 69 participants 72 participants 73 participants 72 participants 27 participants 30 participants 30 participants 30 participants 547 participants
61.0
(35.0 to 81.0)
62.0
(31.0 to 87.0)
61.0
(34.0 to 78.0)
62.0
(29.0 to 80.0)
62.0
(20.0 to 78.0)
62.5
(33.0 to 85.0)
59.0
(37.0 to 81.0)
59.5
(32.0 to 80.0)
61.0
(45.0 to 84.0)
59.0
(35.0 to 84.0)
61.0
(20.0 to 87.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 69 participants 72 participants 73 participants 72 participants 27 participants 30 participants 30 participants 30 participants 547 participants
Female
22
  31.0%
30
  41.1%
34
  49.3%
24
  33.3%
29
  39.7%
37
  51.4%
13
  48.1%
14
  46.7%
10
  33.3%
12
  40.0%
225
  41.1%
Male
49
  69.0%
43
  58.9%
35
  50.7%
48
  66.7%
44
  60.3%
35
  48.6%
14
  51.9%
16
  53.3%
20
  66.7%
18
  60.0%
322
  58.9%
1.Primary Outcome
Title Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
Hide Description Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Time Frame every 6 weeks until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population (ITT) - all subjects who were randomized, with study drug assignment designated according to initial randomization, regardless of whether subjects received any study drug or received a different drug from that to which they were randomized.
Arm/Group Title FOLFIRI mIFL
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Overall Number of Participants Analyzed 144 141
Median (95% Confidence Interval)
Unit of Measure: months
8.18
(7.43 to 8.97)
6.01
(5.52 to 7.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFIRI, mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.433
Confidence Interval 95%
1.09 to 1.89
Estimation Comments Hazard ratio [mIRI:FOLFIRI] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (<=70 vs >70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.
2.Secondary Outcome
Title Time to Progression: FOLFIRI, mIFL and CapeIRI
Hide Description Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Time Frame every 6 weeks until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title FOLFIRI mIFL CapeIRI
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Irinotecan + oral capecitabine with celecoxib or placebo
Overall Number of Participants Analyzed 144 141 145
Median (95% Confidence Interval)
Unit of Measure: months
7.62
(7.06 to 8.71)
5.98
(5.45 to 6.9)
5.82
(4.60 to 6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFIRI, mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0042
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.512
Confidence Interval 95%
1.16 to 1.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FOLFIRI, CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0156
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.368
Confidence Interval 95%
1.04 to 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection mIFL, CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4659
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.057
Confidence Interval 95%
0.81 to 1.38
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Response: FOLFIRI, mIFL and CapeIRI
Hide Description A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )
Time Frame every 6 weeks during chemotherapy until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title FOLFIRI mIFL CapeIRI
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Irinotecan + oral capecitabine with celecoxib or placebo
Overall Number of Participants Analyzed 144 141 145
Measure Type: Number
Unit of Measure: participants
68 61 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 47.2
Confidence Interval 95%
38.85 to 55.71
Estimation Comments Exact confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 43.3
Confidence Interval 95%
34.95 to 51.86
Estimation Comments Exact confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 38.6
Confidence Interval 95%
30.66 to 47.06
Estimation Comments Exact confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FOLFIRI, mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4751
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FOLFIRI, CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1591
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection mIFL, CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4395
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Survival Time: FOLFIRI, mIFL and CapeIRI
Hide Description Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Time Frame assessed at least every week during treatment and at least every 3 months during follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title FOLFIRI mIFL CapeIRI
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Irinotecan + oral capecitabine with celecoxib or placebo
Overall Number of Participants Analyzed 144 141 145
Median (95% Confidence Interval)
Unit of Measure: months
23.06
(17.87 to 26.55)
17.64
(14.29 to 23.03)
18.92
(15.74 to 23.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFIRI, mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0879
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.268
Confidence Interval 95%
0.96 to 1.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FOLFIRI, CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2765
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.190
Confidence Interval 95%
0.90 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection mIFL, CapeIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9364
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.049
Confidence Interval 95%
0.80 to 1.38
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 1 Year Survival: FOLFIRI, mIFL and CapeIRI
Hide Description Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Time Frame 1 year from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title FOLFIRI mIFL CapeIRI
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Irinotecan + oral capecitabine with celecoxib or placebo
Overall Number of Participants Analyzed 144 141 145
Measure Type: Number
Unit of Measure: participants
Alive at 1 year 101 86 89
Dead at 1 year 34 47 46
Censored 9 8 10
6.Secondary Outcome
Title Time to Progression : Celecoxib and Placebo
Hide Description Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Time Frame every 6 weeks until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:
All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
Overall Number of Participants Analyzed 213 217
Median (95% Confidence Interval)
Unit of Measure: months
6.64
(5.68 to 7.39)
6.70
(6.01 to 7.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7163
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.068
Confidence Interval 95%
0.86 to 1.33
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Overall Response: Celecoxib and Placebo
Hide Description A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )
Time Frame every 6 weeks during chemotherapy until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:
All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
Overall Number of Participants Analyzed 213 217
Measure Type: Number
Unit of Measure: participants
84 101
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 39.4
Confidence Interval 95%
32.83 to 46.34
Estimation Comments confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 46.5
Confidence Interval 95%
39.76 to 53.42
Estimation Comments confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1559
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Survival Time: Celecoxib and Placebo
Hide Description Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Time Frame assessed at least every week during treatment and at least every 3 months during follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:
All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
Overall Number of Participants Analyzed 213 217
Median (95% Confidence Interval)
Unit of Measure: months
21.06
(16.92 to 24.28)
18.83
(16.26 to 22.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5316
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.080
Confidence Interval 95%
0.86 to 1.36
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to Progression: Bevacizumab With FOLFIRI, mIFL
Hide Description Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Time Frame every 6 weeks until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bevacizumab + FOLFIRI Bevacizumab + mIFL
Hide Arm/Group Description:
Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
Overall Number of Participants Analyzed 57 60
Median (95% Confidence Interval)
Unit of Measure: months
11.17
(9.00 to 17.41)
8.31
(6.31 to 11.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + FOLFIRI, Bevacizumab + mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2835
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.269
Confidence Interval 95%
0.75 to 2.15
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Overall Response: Bevacizumab With FOLFIRI, mIFL
Hide Description A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )
Time Frame every 6 weeks during chemotherapy until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bevacizumab + FOLFIRI Bevacizumab + mIFL
Hide Arm/Group Description:
Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
Overall Number of Participants Analyzed 57 60
Measure Type: Number
Unit of Measure: participants
33 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 57.9
Confidence Interval 95%
44.08 to 70.86
Estimation Comments Exact confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bevacizumab + mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter F-distribution method
Estimated Value 53.3
Confidence Interval 95%
40.00 to 66.33
Estimation Comments Exact confidence interval for binomial proportion using the F-distribution method (unit: %)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bevacizumab + FOLFIRI, Bevacizumab + mIFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7388
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title 1 Year Survival: Bevacizumab With FOLFIRI, mIFL
Hide Description Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.
Time Frame 1 year from date of randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Bevacizumab + FOLFIRI Bevacizumab + mIRI
Hide Arm/Group Description:
Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
Overall Number of Participants Analyzed 57 60
Measure Type: Number
Unit of Measure: participants
Alive at 1 year 45 33
Dead at 1 year 7 22
Censored 5 5
12.Secondary Outcome
Title Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL
Hide Description Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.
Time Frame Last Follow-Up Visit
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Hide Analysis Population Description
ITT Population.
Arm/Group Title Bevacizumab + FOLFIRI Bevacizumab + mIRI
Hide Arm/Group Description:
Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
Overall Number of Participants Analyzed 57 60
Median (95% Confidence Interval)
Unit of Measure: months
27.99
(23.82 to 34.76)
19.22
(11.60 to 22.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + FOLFIRI, Bevacizumab + mIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0370
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.794
Confidence Interval 95%
1.12 to 2.88
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Dose Reduction Due to Treatment Emergent Adverse Events
Hide Description Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.
Time Frame Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI
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Hide Analysis Population Description
As-Treated population - all subjects who received any study medication, with treatment assignments designated according to actual study treatment received.
Arm/Group Title FOLFIRI mIFL CapeIRI Bevacizumab + FOLFIRI Bevacizumab + mIRI
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Irinotecan + oral capecitabine with celecoxib or placebo
Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
Overall Number of Participants Analyzed 137 137 141 56 59
Measure Type: Number
Unit of Measure: participants
18 14 39 6 8
14.Secondary Outcome
Title Overall Relative Dose Intensity of Irinotecan
Hide Description Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)
Time Frame End of treatment cycle
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Hide Analysis Population Description
As-Treated population
Arm/Group Title FOLFIRI mIFL CapeIRI Bevacizumab + FOLFIRI Bevacizumab + mIRI
Hide Arm/Group Description:
Irinotecan + infusional 5-FU/LV with celecoxib or placebo
Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
Irinotecan + oral capecitabine with celecoxib or placebo
Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
Overall Number of Participants Analyzed 137 137 145 56 59
Mean (Standard Error)
Unit of Measure: percent dose intensity
93.9  (0.6) 94.5  (0.6) 93.8  (0.7) 93.3  (0.8) 95.5  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FOLFIRI mIFL CapeIRI Bevacizumab + FOLFIRI Bevacizumab + mIRI
Hide Arm/Group Description Irinotecan + infusional 5-FU/LV with celecoxib or placebo Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo Irinotecan + oral capecitabine with celecoxib or placebo Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo) Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
All-Cause Mortality
FOLFIRI mIFL CapeIRI Bevacizumab + FOLFIRI Bevacizumab + mIRI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FOLFIRI mIFL CapeIRI Bevacizumab + FOLFIRI Bevacizumab + mIRI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/137 (36.50%)   52/137 (37.96%)   78/141 (55.32%)   19/56 (33.93%)   21/59 (35.59%) 
Blood and lymphatic system disorders           
Coagulopathy  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Febrile neutropenia  1  4/137 (2.92%)  12/137 (8.76%)  8/141 (5.67%)  3/56 (5.36%)  1/59 (1.69%) 
Splenic infarction  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Cardiac disorders           
Angina pectoris  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Arteriosclerosis coronary artery  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Arteriospasm coronary  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Atrial fibrillation  1  1/137 (0.73%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  2/59 (3.39%) 
Myocardial infarction  1  1/137 (0.73%)  4/137 (2.92%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Eye disorders           
Blindness  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Gastrointestinal disorders           
Abdominal discomfort  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Abdominal hernia  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Abdominal pain  1  5/137 (3.65%)  1/137 (0.73%)  6/141 (4.26%)  5/56 (8.93%)  0/59 (0.00%) 
Abdominal pain lower  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Abdominal pain upper  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Abdominal strangulated hernia  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  1/59 (1.69%) 
Ascites  1  0/137 (0.00%)  2/137 (1.46%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Colitis  1  1/137 (0.73%)  0/137 (0.00%)  2/141 (1.42%)  0/56 (0.00%)  0/59 (0.00%) 
Colonic obstruction  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Constipation  1  1/137 (0.73%)  2/137 (1.46%)  0/141 (0.00%)  3/56 (5.36%)  0/59 (0.00%) 
Diarrhoea  1  6/137 (4.38%)  8/137 (5.84%)  42/141 (29.79%)  2/56 (3.57%)  4/59 (6.78%) 
Enteritis  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Enterocolitis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Gastrointestinal disorder  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Gastrointestinal haemorrhage  1  1/137 (0.73%)  1/137 (0.73%)  2/141 (1.42%)  0/56 (0.00%)  0/59 (0.00%) 
Gastrointestinal hypomotility  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Gastrointestinal oedema  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Ileus  1  2/137 (1.46%)  2/137 (1.46%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Intestinal ischaemia  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Intestinal obstruction  1  1/137 (0.73%)  1/137 (0.73%)  5/141 (3.55%)  2/56 (3.57%)  1/59 (1.69%) 
Melaena  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Nausea  1  1/137 (0.73%)  5/137 (3.65%)  20/141 (14.18%)  5/56 (8.93%)  3/59 (5.08%) 
Oesophagitis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Rectal haemorrhage  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Small intestinal obstruction  1  2/137 (1.46%)  3/137 (2.19%)  7/141 (4.96%)  2/56 (3.57%)  1/59 (1.69%) 
Small intestinal perforation  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Stomatitis  1  0/137 (0.00%)  0/137 (0.00%)  2/141 (1.42%)  0/56 (0.00%)  0/59 (0.00%) 
Vomiting  1  5/137 (3.65%)  6/137 (4.38%)  24/141 (17.02%)  5/56 (8.93%)  2/59 (3.39%) 
Abdominal distension  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Duodenal obstruction  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Dysphagia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Intestinal perforation  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Oesophageal spasm  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Oesophageal stenosis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Oesophageal ulcer  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
General disorders           
Asthenia  1  0/137 (0.00%)  2/137 (1.46%)  2/141 (1.42%)  0/56 (0.00%)  1/59 (1.69%) 
Catheter site pain  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Chest pain  1  2/137 (1.46%)  0/137 (0.00%)  1/141 (0.71%)  2/56 (3.57%)  2/59 (3.39%) 
Fatigue  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
General physical health deterioration  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Oedema  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Oedema peripheral  1  1/137 (0.73%)  2/137 (1.46%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Pain  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  1/59 (1.69%) 
Pyrexia  1  5/137 (3.65%)  4/137 (2.92%)  2/141 (1.42%)  0/56 (0.00%)  1/59 (1.69%) 
Mucosal inflammation  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Hepatobiliary disorders           
Bile duct obstruction  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Hepatitis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Jaundice  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Bile duct stenosis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Gallbladder obstruction  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Immune system disorders           
Drug hypersensitivity  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Hypersensitivity  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Infections and infestations           
Abdominal wall abscess  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Bacteraemia  1  2/137 (1.46%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Bronchopneumonia  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Catheter related infection  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Cellulitis  1  2/137 (1.46%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Central line infection  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Clostridium difficile colitis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Device related infection  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Escherichia sepsis  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Gastroenteritis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Infection  1  0/137 (0.00%)  2/137 (1.46%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Influenza  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Lobar pneumonia  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Osteomyelitis  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Pharyngitis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Pneumonia  1  0/137 (0.00%)  2/137 (1.46%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Pyelonephritis  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Sepsis  1  1/137 (0.73%)  1/137 (0.73%)  1/141 (0.71%)  1/56 (1.79%)  1/59 (1.69%) 
Staphylococcal infection  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Systemic candida  1  0/137 (0.00%)  2/137 (1.46%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Upper respiratory tract infection  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Urinary tract infection  1  0/137 (0.00%)  2/137 (1.46%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  1/137 (0.73%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Polytraumatism  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Procedural pain  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Incision site complication  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Procedural site reaction  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Investigations           
Culture stool positive  1  0/137 (0.00%)  2/137 (1.46%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Transaminases increased  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Metabolism and nutrition disorders           
Anorexia  1  4/137 (2.92%)  0/137 (0.00%)  3/141 (2.13%)  0/56 (0.00%)  0/59 (0.00%) 
Dehydration  1  5/137 (3.65%)  7/137 (5.11%)  24/141 (17.02%)  4/56 (7.14%)  1/59 (1.69%) 
Diabetes mellitus inadequate control  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Electrolyte imbalance  1  0/137 (0.00%)  0/137 (0.00%)  2/141 (1.42%)  0/56 (0.00%)  0/59 (0.00%) 
Fluid overload  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Hyperglycaemia  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Hypokalaemia  1  0/137 (0.00%)  2/137 (1.46%)  2/141 (1.42%)  2/56 (3.57%)  0/59 (0.00%) 
Hypovolaemia  1  3/137 (2.19%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Metabolic acidosis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Hypoglycaemia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  1/56 (1.79%)  0/59 (0.00%) 
Fistula  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Flank pain  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Musculoskeletal pain  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Pain in extremity  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Pathological fracture  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Arthralgia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  1/59 (1.69%) 
Chondrocalcinosis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Monarthritis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Neck pain  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Nervous system disorders           
Cerebrovascular accident  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Convulsion  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Depressed level of consciousness  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Dizziness  1  2/137 (1.46%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Hepatic encephalopathy  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Spinal cord compression  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Syncope  1  1/137 (0.73%)  0/137 (0.00%)  2/141 (1.42%)  1/56 (1.79%)  1/59 (1.69%) 
Psychiatric disorders           
Confusional state  1  0/137 (0.00%)  1/137 (0.73%)  3/141 (2.13%)  0/56 (0.00%)  0/59 (0.00%) 
Depression suicidal  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Renal and urinary disorders           
Obstructive uropathy  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Renal failure  1  1/137 (0.73%)  1/137 (0.73%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Renal vein thrombosis  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Urinoma  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Dyspnoea  1  2/137 (1.46%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Lung infiltration  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Pulmonary embolism  1  2/137 (1.46%)  8/137 (5.84%)  8/141 (5.67%)  2/56 (3.57%)  2/59 (3.39%) 
Respiratory arrest  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Respiratory distress  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Respiratory failure  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Alveolitis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Pulmonary oedema  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  1/59 (1.69%) 
Skin and subcutaneous tissue disorders           
Palmar-plantar erythrodysaesthesia syndrome  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  5/137 (3.65%)  5/137 (3.65%)  4/141 (2.84%)  2/56 (3.57%)  1/59 (1.69%) 
Embolism  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Hypertension  1  1/137 (0.73%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Hypotension  1  1/137 (0.73%)  1/137 (0.73%)  1/141 (0.71%)  1/56 (1.79%)  1/59 (1.69%) 
Orthostatic hypotension  1  1/137 (0.73%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Peripheral ischaemia  1  0/137 (0.00%)  0/137 (0.00%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Subclavian vein thrombosis  1  0/137 (0.00%)  1/137 (0.73%)  0/141 (0.00%)  0/56 (0.00%)  0/59 (0.00%) 
Thrombosis  1  2/137 (1.46%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  0/59 (0.00%) 
Haemorrhage  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Jugular vein thrombosis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  0/56 (0.00%)  1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.9%
FOLFIRI mIFL CapeIRI Bevacizumab + FOLFIRI Bevacizumab + mIRI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   135/137 (98.54%)   137/137 (100.00%)   140/141 (99.29%)   56/56 (100.00%)   58/59 (98.31%) 
Blood and lymphatic system disorders           
Febrile neutropenia  1  7/137 (5.11%)  17/137 (12.41%)  10/141 (7.09%)  3/56 (5.36%)  1/59 (1.69%) 
Cardiac disorders           
Palpitations  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  6/56 (10.71%)  0/59 (0.00%) 
Ear and labyrinth disorders           
Vertigo  1  8/137 (5.84%)  3/137 (2.19%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Eye disorders           
Lacrimation increased  1  12/137 (8.76%)  4/137 (2.92%)  16/141 (11.35%)  7/56 (12.50%)  3/59 (5.08%) 
Vision blurred  1  7/137 (5.11%)  5/137 (3.65%)  7/141 (4.96%)  1/56 (1.79%)  4/59 (6.78%) 
Gastrointestinal disorders           
Abdominal discomfort  1  7/137 (5.11%)  2/137 (1.46%)  2/141 (1.42%)  0/56 (0.00%)  0/59 (0.00%) 
Abdominal distension  1  5/137 (3.65%)  11/137 (8.03%)  7/141 (4.96%)  3/56 (5.36%)  4/59 (6.78%) 
Abdominal pain  1  65/137 (47.45%)  50/137 (36.50%)  61/141 (43.26%)  20/56 (35.71%)  18/59 (30.51%) 
Abdominal pain lower  1  0/137 (0.00%)  7/137 (5.11%)  5/141 (3.55%)  3/56 (5.36%)  2/59 (3.39%) 
Abdominal pain upper  1  15/137 (10.95%)  12/137 (8.76%)  14/141 (9.93%)  9/56 (16.07%)  7/59 (11.86%) 
Constipation  1  47/137 (34.31%)  48/137 (35.04%)  36/141 (25.53%)  28/56 (50.00%)  22/59 (37.29%) 
Diarrhoea  1  103/137 (75.18%)  107/137 (78.10%)  126/141 (89.36%)  45/56 (80.36%)  46/59 (77.97%) 
Dyspepsia  1  24/137 (17.52%)  21/137 (15.33%)  21/141 (14.89%)  7/56 (12.50%)  11/59 (18.64%) 
Flatulence  1  16/137 (11.68%)  14/137 (10.22%)  13/141 (9.22%)  7/56 (12.50%)  2/59 (3.39%) 
Haemorrhoids  1  9/137 (6.57%)  4/137 (2.92%)  5/141 (3.55%)  6/56 (10.71%)  7/59 (11.86%) 
Nausea  1  104/137 (75.91%)  93/137 (67.88%)  108/141 (76.60%)  46/56 (82.14%)  37/59 (62.71%) 
Rectal haemorrhage  1  4/137 (2.92%)  8/137 (5.84%)  7/141 (4.96%)  5/56 (8.93%)  4/59 (6.78%) 
Small intestinal obstruction  1  4/137 (2.92%)  3/137 (2.19%)  8/141 (5.67%)  0/56 (0.00%)  0/59 (0.00%) 
Stomatitis  1  52/137 (37.96%)  42/137 (30.66%)  33/141 (23.40%)  27/56 (48.21%)  12/59 (20.34%) 
Vomiting  1  59/137 (43.07%)  61/137 (44.53%)  84/141 (59.57%)  37/56 (66.07%)  16/59 (27.12%) 
Dry mouth  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  5/56 (8.93%)  1/59 (1.69%) 
Dysphagia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  7/56 (12.50%)  3/59 (5.08%) 
Gastrooesophageal reflux disease  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  6/59 (10.17%) 
Haematochezia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Intestinal obstruction  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Proctalgia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  5/59 (8.47%) 
Toothache  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  3/59 (5.08%) 
General disorders           
Asthenia  1  18/137 (13.14%)  17/137 (12.41%)  23/141 (16.31%)  6/56 (10.71%)  7/59 (11.86%) 
Chest pain  1  10/137 (7.30%)  3/137 (2.19%)  8/141 (5.67%)  6/56 (10.71%)  4/59 (6.78%) 
Chills  1  12/137 (8.76%)  14/137 (10.22%)  12/141 (8.51%)  8/56 (14.29%)  3/59 (5.08%) 
Fatigue  1  107/137 (78.10%)  95/137 (69.34%)  82/141 (58.16%)  43/56 (76.79%)  37/59 (62.71%) 
Mucosal inflammation  1  19/137 (13.87%)  13/137 (9.49%)  14/141 (9.93%)  12/56 (21.43%)  6/59 (10.17%) 
Oedema  1  8/137 (5.84%)  6/137 (4.38%)  6/141 (4.26%)  0/56 (0.00%)  0/59 (0.00%) 
Oedema peripheral  1  23/137 (16.79%)  18/137 (13.14%)  24/141 (17.02%)  5/56 (8.93%)  2/59 (3.39%) 
Pyrexia  1  30/137 (21.90%)  28/137 (20.44%)  28/141 (19.86%)  12/56 (21.43%)  6/59 (10.17%) 
Chest discomfort  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  0/59 (0.00%) 
Malaise  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  4/56 (7.14%)  0/59 (0.00%) 
Non-cardiac chest pain  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Pain  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  2/59 (3.39%) 
Infections and infestations           
Herpes simplex  1  8/137 (5.84%)  6/137 (4.38%)  5/141 (3.55%)  0/56 (0.00%)  0/59 (0.00%) 
Infection  1  3/137 (2.19%)  8/137 (5.84%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Nasopharyngitis  1  9/137 (6.57%)  8/137 (5.84%)  4/141 (2.84%)  2/56 (3.57%)  3/59 (5.08%) 
Rhinitis  1  5/137 (3.65%)  7/137 (5.11%)  5/141 (3.55%)  0/56 (0.00%)  0/59 (0.00%) 
Upper respiratory tract infection  1  10/137 (7.30%)  9/137 (6.57%)  5/141 (3.55%)  5/56 (8.93%)  3/59 (5.08%) 
Urinary tract infection  1  4/137 (2.92%)  9/137 (6.57%)  6/141 (4.26%)  6/56 (10.71%)  3/59 (5.08%) 
Catheter site infection  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  0/59 (0.00%) 
Sinusitis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  4/56 (7.14%)  2/59 (3.39%) 
Injury, poisoning and procedural complications           
Procedural pain  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Procedural site reaction  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  2/59 (3.39%) 
Investigations           
Weight decreased  1  10/137 (7.30%)  12/137 (8.76%)  15/141 (10.64%)  5/56 (8.93%)  4/59 (6.78%) 
Weight increased  1  12/137 (8.76%)  9/137 (6.57%)  5/141 (3.55%)  4/56 (7.14%)  4/59 (6.78%) 
Metabolism and nutrition disorders           
Anorexia  1  41/137 (29.93%)  42/137 (30.66%)  48/141 (34.04%)  22/56 (39.29%)  17/59 (28.81%) 
Dehydration  1  24/137 (17.52%)  18/137 (13.14%)  42/141 (29.79%)  9/56 (16.07%)  8/59 (13.56%) 
Hyperglycaemia  1  19/137 (13.87%)  10/137 (7.30%)  12/141 (8.51%)  10/56 (17.86%)  12/59 (20.34%) 
Hypokalaemia  1  13/137 (9.49%)  8/137 (5.84%)  19/141 (13.48%)  11/56 (19.64%)  5/59 (8.47%) 
Hyponatraemia  1  2/137 (1.46%)  8/137 (5.84%)  6/141 (4.26%)  3/56 (5.36%)  0/59 (0.00%) 
Hypoalbuminaemia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  2/56 (3.57%)  3/59 (5.08%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  20/137 (14.60%)  16/137 (11.68%)  13/141 (9.22%)  4/56 (7.14%)  5/59 (8.47%) 
Back pain  1  18/137 (13.14%)  13/137 (9.49%)  11/141 (7.80%)  13/56 (23.21%)  6/59 (10.17%) 
Bone pain  1  9/137 (6.57%)  3/137 (2.19%)  1/141 (0.71%)  0/56 (0.00%)  0/59 (0.00%) 
Muscle spasms  1  8/137 (5.84%)  3/137 (2.19%)  4/141 (2.84%)  0/56 (0.00%)  0/59 (0.00%) 
Muscular weakness  1  3/137 (2.19%)  8/137 (5.84%)  4/141 (2.84%)  0/56 (0.00%)  3/59 (5.08%) 
Musculoskeletal pain  1  9/137 (6.57%)  3/137 (2.19%)  3/141 (2.13%)  7/56 (12.50%)  3/59 (5.08%) 
Myalgia  1  11/137 (8.03%)  7/137 (5.11%)  6/141 (4.26%)  3/56 (5.36%)  7/59 (11.86%) 
Pain in extremity  1  15/137 (10.95%)  12/137 (8.76%)  13/141 (9.22%)  7/56 (12.50%)  3/59 (5.08%) 
Neck pain  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  6/59 (10.17%) 
Nervous system disorders           
Dizziness  1  26/137 (18.98%)  19/137 (13.87%)  12/141 (8.51%)  17/56 (30.36%)  4/59 (6.78%) 
Dysgeusia  1  22/137 (16.06%)  20/137 (14.60%)  20/141 (14.18%)  10/56 (17.86%)  3/59 (5.08%) 
Headache  1  27/137 (19.71%)  24/137 (17.52%)  14/141 (9.93%)  17/56 (30.36%)  9/59 (15.25%) 
Hypoaesthesia  1  7/137 (5.11%)  3/137 (2.19%)  2/141 (1.42%)  0/56 (0.00%)  0/59 (0.00%) 
Peripheral sensory neuropathy  1  9/137 (6.57%)  5/137 (3.65%)  5/141 (3.55%)  5/56 (8.93%)  3/59 (5.08%) 
Syncope  1  7/137 (5.11%)  3/137 (2.19%)  4/141 (2.84%)  0/56 (0.00%)  0/59 (0.00%) 
Neuropathy peripheral  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Psychiatric disorders           
Anxiety  1  15/137 (10.95%)  6/137 (4.38%)  10/141 (7.09%)  7/56 (12.50%)  6/59 (10.17%) 
Confusional state  1  5/137 (3.65%)  5/137 (3.65%)  7/141 (4.96%)  3/56 (5.36%)  1/59 (1.69%) 
Depression  1  16/137 (11.68%)  14/137 (10.22%)  16/141 (11.35%)  8/56 (14.29%)  6/59 (10.17%) 
Insomnia  1  32/137 (23.36%)  31/137 (22.63%)  19/141 (13.48%)  15/56 (26.79%)  14/59 (23.73%) 
Renal and urinary disorders           
Dysuria  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  6/56 (10.71%)  2/59 (3.39%) 
Haematuria  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  2/56 (3.57%)  3/59 (5.08%) 
Urine abnormality  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  20/137 (14.60%)  15/137 (10.95%)  15/141 (10.64%)  19/56 (33.93%)  7/59 (11.86%) 
Dyspnoea  1  34/137 (24.82%)  19/137 (13.87%)  16/141 (11.35%)  10/56 (17.86%)  10/59 (16.95%) 
Epistaxis  1  26/137 (18.98%)  14/137 (10.22%)  2/141 (1.42%)  21/56 (37.50%)  16/59 (27.12%) 
Hiccups  1  10/137 (7.30%)  10/137 (7.30%)  8/141 (5.67%)  5/56 (8.93%)  6/59 (10.17%) 
Nasal congestion  1  8/137 (5.84%)  5/137 (3.65%)  6/141 (4.26%)  5/56 (8.93%)  1/59 (1.69%) 
Pharyngolaryngeal pain  1  9/137 (6.57%)  6/137 (4.38%)  6/141 (4.26%)  9/56 (16.07%)  5/59 (8.47%) 
Pulmonary embolism  1  3/137 (2.19%)  10/137 (7.30%)  8/141 (5.67%)  0/56 (0.00%)  0/59 (0.00%) 
Rhinorrhoea  1  13/137 (9.49%)  6/137 (4.38%)  4/141 (2.84%)  6/56 (10.71%)  3/59 (5.08%) 
Dysphonia  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  7/56 (12.50%)  2/59 (3.39%) 
Dyspnoea exertional  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  2/59 (3.39%) 
Rhinitis allergic  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  4/56 (7.14%)  3/59 (5.08%) 
Sinus congestion  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  4/59 (6.78%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  64/137 (46.72%)  57/137 (41.61%)  61/141 (43.26%)  21/56 (37.50%)  11/59 (18.64%) 
Dry skin  1  11/137 (8.03%)  7/137 (5.11%)  6/141 (4.26%)  13/56 (23.21%)  4/59 (6.78%) 
Hyperhidrosis  1  15/137 (10.95%)  8/137 (5.84%)  9/141 (6.38%)  2/56 (3.57%)  5/59 (8.47%) 
Palmar-plantar erythrodysaesthesia syndrome  1  14/137 (10.22%)  7/137 (5.11%)  67/141 (47.52%)  12/56 (21.43%)  1/59 (1.69%) 
Pruritus  1  10/137 (7.30%)  5/137 (3.65%)  6/141 (4.26%)  5/56 (8.93%)  4/59 (6.78%) 
Rash  1  20/137 (14.60%)  17/137 (12.41%)  22/141 (15.60%)  16/56 (28.57%)  7/59 (11.86%) 
Erythema  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  1/59 (1.69%) 
Night sweats  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  2/59 (3.39%) 
Pigmentation disorder  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  3/56 (5.36%)  0/59 (0.00%) 
Surgical and medical procedures           
Sinus operation  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  3/59 (5.08%) 
Vascular disorders           
Deep vein thrombosis  1  17/137 (12.41%)  11/137 (8.03%)  11/141 (7.80%)  5/56 (8.93%)  2/59 (3.39%) 
Flushing  1  15/137 (10.95%)  5/137 (3.65%)  4/141 (2.84%)  3/56 (5.36%)  2/59 (3.39%) 
Hot flush  1  10/137 (7.30%)  5/137 (3.65%)  5/141 (3.55%)  5/56 (8.93%)  4/59 (6.78%) 
Hypertension  1  7/137 (5.11%)  3/137 (2.19%)  3/141 (2.13%)  12/56 (21.43%)  12/59 (20.34%) 
Hypotension  1  8/137 (5.84%)  6/137 (4.38%)  7/141 (4.96%)  0/56 (0.00%)  0/59 (0.00%) 
Haemorrhage  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  1/56 (1.79%)  3/59 (5.08%) 
Thrombosis  1  0/137 (0.00%)  0/137 (0.00%)  0/141 (0.00%)  4/56 (7.14%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00101686     History of Changes
Other Study ID Numbers: CPTAIV-0020-411
A5961021
First Submitted: January 12, 2005
First Posted: January 13, 2005
Results First Submitted: October 20, 2009
Results First Posted: November 26, 2009
Last Update Posted: January 12, 2010