We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

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: NCT00339183
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : May 6, 2014
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Panitumumab
Drug: FOLFIRI
Enrollment 1186
Recruitment Details First patient enrolled 30 June 2006; Last patient enrolled 13 March 2008.
Pre-assignment Details  
Arm/Group Title Panitumumab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group Description Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks. Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
Period Title: Overall Study
Started 591 595
Received Study Drug 588 [1] 593
Completed 470 [2] 490 [2]
Not Completed 121 105
Reason Not Completed
Adverse Event             5             3
Withdrawal by Subject             16             19
Physician Decision             2             4
Lost to Follow-up             17             17
Protocol-specified criteria             12             8
Missing reason             3             1
Other             46             40
Ongoing             20             13
[1]
Includes one participant who received FOLFIRI Alone
[2]
Indicates participants who had completed the safety visit 30 days after last dose or had died
Arm/Group Title Panitumumab Plus FOLFIRI FOLFIRI Alone Total
Hide Arm/Group Description Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks. Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks. Total of all reporting groups
Overall Number of Baseline Participants 591 595 1186
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 591 participants 595 participants 1186 participants
60.2  (10.5) 60.9  (10.6) 60.6  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 591 participants 595 participants 1186 participants
Female
245
  41.5%
219
  36.8%
464
  39.1%
Male
346
  58.5%
376
  63.2%
722
  60.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants 595 participants 1186 participants
White or Caucasian 568 569 1137
Black or African American 4 5 9
Hispanic or Latino 2 3 5
Asian 2 3 5
Japanese 9 11 20
Native Hawaiian or Other Pacific Islander 1 1 2
Aborigine 2 1 3
Other 3 2 5
KRAS Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants 595 participants 1186 participants
Wild-type KRAS 303 294 597
Mutant KRAS 238 248 486
Unevaluable KRAS 50 53 103
[1]
Measure Description: KRAS, the human homolog of the Kirsten rat sarcoma-2 virus oncogene
Prior Oxaliplatin Exposure for mCRC   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants 595 participants 1186 participants
No 179 182 361
Yes 412 413 825
[1]
Measure Description: mCRC: metastatic colorectal cancer
Prior Bevacizumab Exposure for mCRC  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants 595 participants 1186 participants
No 480 483 963
Yes 111 112 223
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 591 participants 595 participants 1186 participants
Grade 0 or 1 564 565 1129
Grade 2 27 30 57
[1]
Measure Description: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; Grade 3: Capable of only limited self care, confined to a bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5: Dead
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description

Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.

Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.

Time Frame From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)
Arm/Group Title Wild-type KRAS - Panitumumab Plus FOLFIRI Wild-type KRAS - FOLFIRI Alone Mutant KRAS - Panitumumab Plus FOLFIRI Mutant KRAS - FOLFIRI Alone
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Overall Number of Participants Analyzed 303 294 238 248
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(5.5 to 6.7)
3.9
(3.7 to 5.3)
5.0
(3.8 to 5.6)
4.9
(3.6 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wild-type KRAS - Panitumumab Plus FOLFIRI, Wild-type KRAS - FOLFIRI Alone
Comments An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Stratified log-rank test
Comments P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
Method of Estimation Estimation Parameter Normal score
Estimated Value -2.91
Estimation Comments A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mutant KRAS - Panitumumab Plus FOLFIRI, Mutant KRAS - FOLFIRI Alone
Comments PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1448
Comments [Not Specified]
Method Stratified log-rank test
Comments P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).
Method of Estimation Estimation Parameter Normal score
Estimated Value -1.46
Estimation Comments A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.
2.Primary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.
Time Frame From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Efficacy Analysis Set
Arm/Group Title Wild-type KRAS - Panitumumab Plus FOLFIRI Wild-type KRAS - FOLFIRI Alone Mutant KRAS - Panitumumab Plus FOLFIRI Mutant KRAS - FOLFIRI Alone
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Overall Number of Participants Analyzed 303 294 238 248
Median (95% Confidence Interval)
Unit of Measure: months
14.5
(13.0 to 16.0)
12.5
(11.2 to 14.2)
11.8
(10.4 to 13.3)
11.1
(10.3 to 12.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wild-type KRAS - Panitumumab Plus FOLFIRI, Wild-type KRAS - FOLFIRI Alone
Comments An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1154
Comments [Not Specified]
Method Stratified log-rank test
Comments P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
Method of Estimation Estimation Parameter Normal score
Estimated Value -1.57
Estimation Comments A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mutant KRAS - Panitumumab Plus FOLFIRI, Mutant KRAS - FOLFIRI Alone
Comments The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5503
Comments [Not Specified]
Method Stratified log-rank test
Comments P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).
Method of Estimation Estimation Parameter Normal score
Estimated Value -0.60
Estimation Comments A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.
3.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.
Time Frame Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.
Arm/Group Title Wild-type KRAS - Panitumumab Plus FOLFIRI Wild-type KRAS - FOLFIRI Alone Mutant KRAS - Panitumumab Plus FOLFIRI Mutant KRAS - FOLFIRI Alone
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Overall Number of Participants Analyzed 297 285 232 237
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.35
(29.92 to 41.08)
9.82
(6.63 to 13.89)
13.36
(9.26 to 18.43)
13.92
(9.78 to 19.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wild-type KRAS - Panitumumab Plus FOLFIRI, Wild-type KRAS - FOLFIRI Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified exact test
Comments Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.33
Confidence Interval (2-Sided) 95%
3.21 to 8.60
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mutant KRAS - Panitumumab Plus FOLFIRI, Mutant KRAS - FOLFIRI Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Stratified exact test
Comments Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.56 to 1.76
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.
4.Secondary Outcome
Title Time to Disease Progression
Hide Description

Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.

Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.

Time Frame From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Efficacy Analysis Set
Arm/Group Title Wild-type KRAS - Panitumumab Plus FOLFIRI Wild-type KRAS - FOLFIRI Alone Mutant KRAS - Panitumumab Plus FOLFIRI Mutant KRAS - FOLFIRI Alone
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Overall Number of Participants Analyzed 303 294 238 248
Median (95% Confidence Interval)
Unit of Measure: months
7.3
(5.9 to 7.5)
5.3
(3.9 to 5.7)
5.5
(4.5 to 5.7)
5.5
(4.2 to 5.7)
5.Secondary Outcome
Title Duration of Response
Hide Description

Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.

Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.

Time Frame From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Central Tumor Response Analysis Set: Responders
Arm/Group Title Wild-type KRAS - Panitumumab Plus FOLFIRI Wild-type KRAS - FOLFIRI Alone Mutant KRAS - Panitumumab Plus FOLFIRI Mutant KRAS - FOLFIRI Alone
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Overall Number of Participants Analyzed 105 28 31 33
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(6.7 to 9.4)
6.6
(5.7 to 10.4)
6.0
(5.4 to 7.4)
7.4
(4.0 to 8.1)
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
Time Frame From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.
Arm/Group Title Panitumumab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
Overall Number of Participants Analyzed 587 594
Measure Type: Number
Unit of Measure: participants
Any adverse event 584 573
Serious adverse event 232 175
Leading to discontinuation of any study drug 123 64
Treatment-related adverse event (TRAE) 577 542
Serious treatment-related adverse event 124 90
TRAE leading to discontinuation of any study drug 97 34
Time Frame The median treatment period was approximately 6.2 months in the Panitumumab plus FOLFIRI arm, and 4.7 months in the FOLFIRI Alone arm.
Adverse Event Reporting Description

One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

 
Arm/Group Title Panitumumab Plus FOLFIRI FOLFIRI Alone
Hide Arm/Group Description Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks. Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
All-Cause Mortality
Panitumumab Plus FOLFIRI FOLFIRI Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Panitumumab Plus FOLFIRI FOLFIRI Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   232/587 (39.52%)   175/594 (29.46%) 
Blood and lymphatic system disorders     
Anaemia  1  5/587 (0.85%)  5/594 (0.84%) 
Disseminated intravascular coagulation  1  1/587 (0.17%)  0/594 (0.00%) 
Febrile bone marrow aplasia  1  2/587 (0.34%)  0/594 (0.00%) 
Febrile neutropenia  1  11/587 (1.87%)  16/594 (2.69%) 
Leukopenia  1  4/587 (0.68%)  0/594 (0.00%) 
Neutropenia  1  6/587 (1.02%)  12/594 (2.02%) 
Pancytopenia  1  1/587 (0.17%)  0/594 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/587 (0.17%)  0/594 (0.00%) 
Angina pectoris  1  1/587 (0.17%)  0/594 (0.00%) 
Arrhythmia  1  1/587 (0.17%)  0/594 (0.00%) 
Arteriospasm coronary  1  1/587 (0.17%)  1/594 (0.17%) 
Bradycardia  1  0/587 (0.00%)  1/594 (0.17%) 
Cardiac arrest  1  0/587 (0.00%)  1/594 (0.17%) 
Cardiac failure  1  0/587 (0.00%)  1/594 (0.17%) 
Cardiac failure acute  1  1/587 (0.17%)  1/594 (0.17%) 
Cardio-respiratory arrest  1  1/587 (0.17%)  0/594 (0.00%) 
Cardiopulmonary failure  1  1/587 (0.17%)  0/594 (0.00%) 
Myocardial infarction  1  1/587 (0.17%)  1/594 (0.17%) 
Palpitations  1  1/587 (0.17%)  0/594 (0.00%) 
Sinus bradycardia  1  1/587 (0.17%)  0/594 (0.00%) 
Sinus tachycardia  1  1/587 (0.17%)  0/594 (0.00%) 
Tachycardia  1  0/587 (0.00%)  2/594 (0.34%) 
Congenital, familial and genetic disorders     
Aplasia  1  2/587 (0.34%)  1/594 (0.17%) 
Ear and labyrinth disorders     
Vertigo  1  0/587 (0.00%)  1/594 (0.17%) 
Eye disorders     
Diplopia  1  0/587 (0.00%)  1/594 (0.17%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/587 (0.00%)  1/594 (0.17%) 
Abdominal hernia  1  0/587 (0.00%)  1/594 (0.17%) 
Abdominal pain  1  12/587 (2.04%)  13/594 (2.19%) 
Abdominal pain lower  1  1/587 (0.17%)  1/594 (0.17%) 
Abdominal pain upper  1  2/587 (0.34%)  1/594 (0.17%) 
Anal fistula  1  1/587 (0.17%)  1/594 (0.17%) 
Anal haemorrhage  1  1/587 (0.17%)  0/594 (0.00%) 
Anal ulcer  1  1/587 (0.17%)  0/594 (0.00%) 
Anorectal disorder  1  1/587 (0.17%)  0/594 (0.00%) 
Ascites  1  0/587 (0.00%)  3/594 (0.51%) 
Colitis  1  1/587 (0.17%)  1/594 (0.17%) 
Colonic obstruction  1  2/587 (0.34%)  4/594 (0.67%) 
Colonic stenosis  1  0/587 (0.00%)  1/594 (0.17%) 
Constipation  1  2/587 (0.34%)  3/594 (0.51%) 
Diarrhoea  1  33/587 (5.62%)  23/594 (3.87%) 
Duodenal obstruction  1  1/587 (0.17%)  0/594 (0.00%) 
Dyspepsia  1  1/587 (0.17%)  1/594 (0.17%) 
Dysphagia  1  0/587 (0.00%)  1/594 (0.17%) 
Enterocolitis haemorrhagic  1  1/587 (0.17%)  0/594 (0.00%) 
Faecal vomiting  1  0/587 (0.00%)  1/594 (0.17%) 
Flatulence  1  1/587 (0.17%)  0/594 (0.00%) 
Gastric haemorrhage  1  0/587 (0.00%)  1/594 (0.17%) 
Gastritis haemorrhagic  1  1/587 (0.17%)  0/594 (0.00%) 
Gastrointestinal obstruction  1  0/587 (0.00%)  2/594 (0.34%) 
Gastrointestinal toxicity  1  1/587 (0.17%)  0/594 (0.00%) 
Haematemesis  1  0/587 (0.00%)  1/594 (0.17%) 
Haematochezia  1  0/587 (0.00%)  1/594 (0.17%) 
Ileal perforation  1  0/587 (0.00%)  1/594 (0.17%) 
Ileus  1  4/587 (0.68%)  4/594 (0.67%) 
Intestinal obstruction  1  9/587 (1.53%)  9/594 (1.52%) 
Intestinal perforation  1  1/587 (0.17%)  0/594 (0.00%) 
Nausea  1  12/587 (2.04%)  5/594 (0.84%) 
Neutropenic colitis  1  0/587 (0.00%)  1/594 (0.17%) 
Oesophagitis ulcerative  1  0/587 (0.00%)  1/594 (0.17%) 
Pancreatitis  1  1/587 (0.17%)  1/594 (0.17%) 
Proctalgia  1  1/587 (0.17%)  1/594 (0.17%) 
Proctitis  1  0/587 (0.00%)  1/594 (0.17%) 
Rectal haemorrhage  1  3/587 (0.51%)  1/594 (0.17%) 
Reflux oesophagitis  1  1/587 (0.17%)  0/594 (0.00%) 
Retroperitoneal haemorrhage  1  1/587 (0.17%)  0/594 (0.00%) 
Sigmoiditis  1  0/587 (0.00%)  1/594 (0.17%) 
Small intestinal obstruction  1  6/587 (1.02%)  4/594 (0.67%) 
Stomatitis  1  1/587 (0.17%)  3/594 (0.51%) 
Subileus  1  2/587 (0.34%)  4/594 (0.67%) 
Umbilical hernia  1  0/587 (0.00%)  1/594 (0.17%) 
Volvulus  1  1/587 (0.17%)  0/594 (0.00%) 
Vomiting  1  17/587 (2.90%)  13/594 (2.19%) 
General disorders     
Accidental death  1  1/587 (0.17%)  0/594 (0.00%) 
Asthenia  1  8/587 (1.36%)  1/594 (0.17%) 
Catheter related complication  1  2/587 (0.34%)  0/594 (0.00%) 
Catheter site related reaction  1  1/587 (0.17%)  0/594 (0.00%) 
Catheter thrombosis  1  1/587 (0.17%)  1/594 (0.17%) 
Chest discomfort  1  0/587 (0.00%)  1/594 (0.17%) 
Chest pain  1  3/587 (0.51%)  3/594 (0.51%) 
Chills  1  1/587 (0.17%)  2/594 (0.34%) 
Death  1  1/587 (0.17%)  0/594 (0.00%) 
Fatigue  1  5/587 (0.85%)  5/594 (0.84%) 
Gait disturbance  1  0/587 (0.00%)  1/594 (0.17%) 
General physical health deterioration  1  6/587 (1.02%)  8/594 (1.35%) 
Generalised oedema  1  1/587 (0.17%)  0/594 (0.00%) 
Hyperthermia  1  2/587 (0.34%)  0/594 (0.00%) 
Malaise  1  1/587 (0.17%)  2/594 (0.34%) 
Mucosal inflammation  1  2/587 (0.34%)  4/594 (0.67%) 
Multi-organ failure  1  1/587 (0.17%)  0/594 (0.00%) 
Oedema peripheral  1  0/587 (0.00%)  1/594 (0.17%) 
Pain  1  7/587 (1.19%)  1/594 (0.17%) 
Performance status decreased  1  4/587 (0.68%)  0/594 (0.00%) 
Pyrexia  1  24/587 (4.09%)  16/594 (2.69%) 
Sudden death  1  2/587 (0.34%)  1/594 (0.17%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/587 (0.17%)  1/594 (0.17%) 
Biliary colic  1  1/587 (0.17%)  0/594 (0.00%) 
Biliary dilatation  1  1/587 (0.17%)  0/594 (0.00%) 
Cholangiolitis  1  1/587 (0.17%)  0/594 (0.00%) 
Cholangitis  1  1/587 (0.17%)  3/594 (0.51%) 
Cholestasis  1  2/587 (0.34%)  1/594 (0.17%) 
Hepatic failure  1  0/587 (0.00%)  1/594 (0.17%) 
Hyperbilirubinaemia  1  2/587 (0.34%)  0/594 (0.00%) 
Jaundice  1  1/587 (0.17%)  1/594 (0.17%) 
Jaundice cholestatic  1  1/587 (0.17%)  0/594 (0.00%) 
Portal vein thrombosis  1  1/587 (0.17%)  0/594 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  1/587 (0.17%)  0/594 (0.00%) 
Drug hypersensitivity  1  0/587 (0.00%)  1/594 (0.17%) 
Infections and infestations     
Abdominal abscess  1  1/587 (0.17%)  2/594 (0.34%) 
Abdominal infection  1  1/587 (0.17%)  0/594 (0.00%) 
Abscess  1  0/587 (0.00%)  1/594 (0.17%) 
Actinomycotic pulmonary infection  1  0/587 (0.00%)  1/594 (0.17%) 
Bacteraemia  1  2/587 (0.34%)  1/594 (0.17%) 
Biliary sepsis  1  0/587 (0.00%)  1/594 (0.17%) 
Bronchitis  1  1/587 (0.17%)  1/594 (0.17%) 
Campylobacter infection  1  1/587 (0.17%)  0/594 (0.00%) 
Candida sepsis  1  1/587 (0.17%)  0/594 (0.00%) 
Candidiasis  1  0/587 (0.00%)  1/594 (0.17%) 
Catheter related infection  1  7/587 (1.19%)  3/594 (0.51%) 
Catheter sepsis  1  1/587 (0.17%)  0/594 (0.00%) 
Catheter site infection  1  1/587 (0.17%)  0/594 (0.00%) 
Cellulitis  1  6/587 (1.02%)  1/594 (0.17%) 
Device related infection  1  1/587 (0.17%)  0/594 (0.00%) 
Escherichia sepsis  1  0/587 (0.00%)  1/594 (0.17%) 
Febrile infection  1  0/587 (0.00%)  1/594 (0.17%) 
Gastroenteritis  1  0/587 (0.00%)  1/594 (0.17%) 
Gastroenteritis viral  1  1/587 (0.17%)  0/594 (0.00%) 
Infection  1  3/587 (0.51%)  1/594 (0.17%) 
Influenza  1  1/587 (0.17%)  0/594 (0.00%) 
Klebsiella infection  1  0/587 (0.00%)  1/594 (0.17%) 
Lower respiratory tract infection  1  0/587 (0.00%)  1/594 (0.17%) 
Neutropenic sepsis  1  1/587 (0.17%)  1/594 (0.17%) 
Oropharyngitis fungal  1  1/587 (0.17%)  0/594 (0.00%) 
Pneumonia  1  4/587 (0.68%)  4/594 (0.67%) 
Post procedural infection  1  1/587 (0.17%)  0/594 (0.00%) 
Pyelonephritis  1  1/587 (0.17%)  1/594 (0.17%) 
Pyelonephritis acute  1  1/587 (0.17%)  0/594 (0.00%) 
Respiratory tract infection  1  1/587 (0.17%)  2/594 (0.34%) 
Sepsis  1  4/587 (0.68%)  3/594 (0.51%) 
Septic shock  1  1/587 (0.17%)  2/594 (0.34%) 
Staphylococcal infection  1  0/587 (0.00%)  1/594 (0.17%) 
Staphylococcal sepsis  1  2/587 (0.34%)  0/594 (0.00%) 
Subcutaneous abscess  1  3/587 (0.51%)  1/594 (0.17%) 
Upper respiratory tract infection  1  0/587 (0.00%)  1/594 (0.17%) 
Urinary tract infection  1  5/587 (0.85%)  3/594 (0.51%) 
Urosepsis  1  2/587 (0.34%)  1/594 (0.17%) 
Vaginitis bacterial  1  1/587 (0.17%)  0/594 (0.00%) 
Viral infection  1  1/587 (0.17%)  0/594 (0.00%) 
Wound infection  1  1/587 (0.17%)  0/594 (0.00%) 
Injury, poisoning and procedural complications     
Concussion  1  1/587 (0.17%)  0/594 (0.00%) 
Contrast media reaction  1  0/587 (0.00%)  1/594 (0.17%) 
Drug administration error  1  1/587 (0.17%)  0/594 (0.00%) 
Femur fracture  1  1/587 (0.17%)  1/594 (0.17%) 
Gastrointestinal stoma complication  1  0/587 (0.00%)  1/594 (0.17%) 
Incisional hernia  1  0/587 (0.00%)  1/594 (0.17%) 
Joint injury  1  0/587 (0.00%)  1/594 (0.17%) 
Overdose  1  1/587 (0.17%)  0/594 (0.00%) 
Perinephric collection  1  1/587 (0.17%)  0/594 (0.00%) 
Post procedural complication  1  1/587 (0.17%)  0/594 (0.00%) 
Post procedural haemorrhage  1  0/587 (0.00%)  1/594 (0.17%) 
Postoperative respiratory distress  1  0/587 (0.00%)  1/594 (0.17%) 
Procedural site reaction  1  1/587 (0.17%)  0/594 (0.00%) 
Subdural haematoma  1  0/587 (0.00%)  1/594 (0.17%) 
Subdural haemorrhage  1  0/587 (0.00%)  1/594 (0.17%) 
Investigations     
Alanine aminotransferase increased  1  1/587 (0.17%)  0/594 (0.00%) 
Aspartate aminotransferase increased  1  1/587 (0.17%)  0/594 (0.00%) 
Blood creatinine increased  1  0/587 (0.00%)  1/594 (0.17%) 
General physical condition abnormal  1  0/587 (0.00%)  1/594 (0.17%) 
Haemoglobin decreased  1  2/587 (0.34%)  0/594 (0.00%) 
Weight decreased  1  1/587 (0.17%)  0/594 (0.00%) 
White blood cell count decreased  1  0/587 (0.00%)  1/594 (0.17%) 
Metabolism and nutrition disorders     
Anorexia  1  3/587 (0.51%)  3/594 (0.51%) 
Dehydration  1  20/587 (3.41%)  11/594 (1.85%) 
Diabetes mellitus  1  0/587 (0.00%)  1/594 (0.17%) 
Failure to thrive  1  1/587 (0.17%)  0/594 (0.00%) 
Hyperglycaemia  1  2/587 (0.34%)  1/594 (0.17%) 
Hyperkalaemia  1  0/587 (0.00%)  1/594 (0.17%) 
Hypocalcaemia  1  1/587 (0.17%)  0/594 (0.00%) 
Hypokalaemia  1  6/587 (1.02%)  0/594 (0.00%) 
Hypomagnesaemia  1  4/587 (0.68%)  0/594 (0.00%) 
Hypoproteinaemia  1  1/587 (0.17%)  0/594 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/587 (0.17%)  2/594 (0.34%) 
Back pain  1  3/587 (0.51%)  6/594 (1.01%) 
Bone pain  1  1/587 (0.17%)  0/594 (0.00%) 
Flank pain  1  1/587 (0.17%)  0/594 (0.00%) 
Groin pain  1  1/587 (0.17%)  0/594 (0.00%) 
Hip swelling  1  1/587 (0.17%)  0/594 (0.00%) 
Muscle atrophy  1  1/587 (0.17%)  0/594 (0.00%) 
Muscular weakness  1  1/587 (0.17%)  0/594 (0.00%) 
Musculoskeletal pain  1  1/587 (0.17%)  0/594 (0.00%) 
Pain in extremity  1  1/587 (0.17%)  0/594 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma  1  0/587 (0.00%)  1/594 (0.17%) 
Colon cancer metastatic  1  2/587 (0.34%)  1/594 (0.17%) 
Colorectal cancer metastatic  1  9/587 (1.53%)  10/594 (1.68%) 
Gastrointestinal cancer metastatic  1  1/587 (0.17%)  0/594 (0.00%) 
Malignant ascites  1  0/587 (0.00%)  1/594 (0.17%) 
Malignant neoplasm progression  1  1/587 (0.17%)  0/594 (0.00%) 
Malignant peritoneal neoplasm  1  1/587 (0.17%)  1/594 (0.17%) 
Metastases to bone  1  2/587 (0.34%)  0/594 (0.00%) 
Metastases to central nervous system  1  3/587 (0.51%)  1/594 (0.17%) 
Metastases to liver  1  1/587 (0.17%)  0/594 (0.00%) 
Metastatic neoplasm  1  1/587 (0.17%)  0/594 (0.00%) 
Tumour associated fever  1  1/587 (0.17%)  0/594 (0.00%) 
Tumour haemorrhage  1  0/587 (0.00%)  1/594 (0.17%) 
Tumour local invasion  1  0/587 (0.00%)  1/594 (0.17%) 
Nervous system disorders     
Ataxia  1  2/587 (0.34%)  0/594 (0.00%) 
Brain oedema  1  1/587 (0.17%)  0/594 (0.00%) 
Cerebral haemorrhage  1  1/587 (0.17%)  0/594 (0.00%) 
Cerebral infarction  1  0/587 (0.00%)  1/594 (0.17%) 
Cerebral ischaemia  1  1/587 (0.17%)  0/594 (0.00%) 
Cerebrovascular accident  1  0/587 (0.00%)  3/594 (0.51%) 
Cerebrovascular insufficiency  1  0/587 (0.00%)  1/594 (0.17%) 
Cholinergic syndrome  1  1/587 (0.17%)  1/594 (0.17%) 
Chorea  1  1/587 (0.17%)  0/594 (0.00%) 
Coma  1  1/587 (0.17%)  0/594 (0.00%) 
Depressed level of consciousness  1  0/587 (0.00%)  1/594 (0.17%) 
Dizziness  1  0/587 (0.00%)  1/594 (0.17%) 
Epiduritis  1  1/587 (0.17%)  0/594 (0.00%) 
Epilepsy  1  1/587 (0.17%)  0/594 (0.00%) 
Headache  1  1/587 (0.17%)  0/594 (0.00%) 
Hemiplegia  1  2/587 (0.34%)  0/594 (0.00%) 
Lethargy  1  1/587 (0.17%)  0/594 (0.00%) 
Loss of consciousness  1  0/587 (0.00%)  2/594 (0.34%) 
Nervous system disorder  1  1/587 (0.17%)  0/594 (0.00%) 
Partial seizures  1  1/587 (0.17%)  0/594 (0.00%) 
Sciatica  1  1/587 (0.17%)  0/594 (0.00%) 
Spinal cord compression  1  1/587 (0.17%)  1/594 (0.17%) 
Status epilepticus  1  1/587 (0.17%)  0/594 (0.00%) 
Syncope  1  2/587 (0.34%)  1/594 (0.17%) 
Psychiatric disorders     
Anxiety  1  0/587 (0.00%)  1/594 (0.17%) 
Confusional state  1  0/587 (0.00%)  1/594 (0.17%) 
Mental status changes  1  1/587 (0.17%)  1/594 (0.17%) 
Mood altered  1  0/587 (0.00%)  1/594 (0.17%) 
Panic attack  1  0/587 (0.00%)  1/594 (0.17%) 
Psychotic disorder  1  0/587 (0.00%)  1/594 (0.17%) 
Renal and urinary disorders     
Dysuria  1  1/587 (0.17%)  0/594 (0.00%) 
Haematuria  1  1/587 (0.17%)  1/594 (0.17%) 
Hydronephrosis  1  2/587 (0.34%)  0/594 (0.00%) 
Renal colic  1  2/587 (0.34%)  0/594 (0.00%) 
Renal failure  1  1/587 (0.17%)  2/594 (0.34%) 
Renal failure acute  1  3/587 (0.51%)  3/594 (0.51%) 
Ureteric obstruction  1  1/587 (0.17%)  1/594 (0.17%) 
Urinary retention  1  1/587 (0.17%)  0/594 (0.00%) 
Urinary tract obstruction  1  1/587 (0.17%)  0/594 (0.00%) 
Reproductive system and breast disorders     
Genital ulceration  1  1/587 (0.17%)  0/594 (0.00%) 
Pelvic pain  1  1/587 (0.17%)  0/594 (0.00%) 
Perineal fistula  1  0/587 (0.00%)  1/594 (0.17%) 
Vulvovaginal pain  1  1/587 (0.17%)  0/594 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  1/587 (0.17%)  0/594 (0.00%) 
Dyspnoea  1  4/587 (0.68%)  4/594 (0.67%) 
Dyspnoea exertional  1  1/587 (0.17%)  0/594 (0.00%) 
Haemoptysis  1  0/587 (0.00%)  2/594 (0.34%) 
Hypoxia  1  1/587 (0.17%)  0/594 (0.00%) 
Interstitial lung disease  1  1/587 (0.17%)  0/594 (0.00%) 
Lung disorder  1  0/587 (0.00%)  1/594 (0.17%) 
Lung infiltration  1  0/587 (0.00%)  1/594 (0.17%) 
Pleural effusion  1  3/587 (0.51%)  0/594 (0.00%) 
Pneumonitis  1  1/587 (0.17%)  0/594 (0.00%) 
Pneumothorax  1  1/587 (0.17%)  1/594 (0.17%) 
Productive cough  1  0/587 (0.00%)  1/594 (0.17%) 
Pulmonary embolism  1  17/587 (2.90%)  10/594 (1.68%) 
Respiratory distress  1  0/587 (0.00%)  1/594 (0.17%) 
Respiratory failure  1  0/587 (0.00%)  2/594 (0.34%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/587 (0.17%)  0/594 (0.00%) 
Dermal cyst  1  1/587 (0.17%)  0/594 (0.00%) 
Dermatitis acneiform  1  3/587 (0.51%)  0/594 (0.00%) 
Dermatitis contact  1  1/587 (0.17%)  0/594 (0.00%) 
Erythema  1  1/587 (0.17%)  0/594 (0.00%) 
Pruritus  1  1/587 (0.17%)  0/594 (0.00%) 
Rash  1  5/587 (0.85%)  0/594 (0.00%) 
Skin exfoliation  1  1/587 (0.17%)  0/594 (0.00%) 
Skin toxicity  1  3/587 (0.51%)  0/594 (0.00%) 
Surgical and medical procedures     
Liver operation  1  0/587 (0.00%)  1/594 (0.17%) 
Stent placement  1  0/587 (0.00%)  1/594 (0.17%) 
Vascular disorders     
Aortic aneurysm  1  0/587 (0.00%)  1/594 (0.17%) 
Deep vein thrombosis  1  7/587 (1.19%)  2/594 (0.34%) 
Embolism  1  0/587 (0.00%)  1/594 (0.17%) 
Embolism venous  1  0/587 (0.00%)  1/594 (0.17%) 
Haematoma  1  0/587 (0.00%)  1/594 (0.17%) 
Hypertension  1  1/587 (0.17%)  0/594 (0.00%) 
Hypotension  1  2/587 (0.34%)  0/594 (0.00%) 
Orthostatic hypotension  1  1/587 (0.17%)  0/594 (0.00%) 
Pelvic venous thrombosis  1  0/587 (0.00%)  1/594 (0.17%) 
Thrombophlebitis  1  1/587 (0.17%)  0/594 (0.00%) 
Thrombosis  1  4/587 (0.68%)  2/594 (0.34%) 
Vena cava thrombosis  1  1/587 (0.17%)  1/594 (0.17%) 
Venous thrombosis  1  1/587 (0.17%)  2/594 (0.34%) 
Venous thrombosis limb  1  2/587 (0.34%)  0/594 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab Plus FOLFIRI FOLFIRI Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   575/587 (97.96%)   546/594 (91.92%) 
Blood and lymphatic system disorders     
Anaemia  1  79/587 (13.46%)  110/594 (18.52%) 
Leukopenia  1  64/587 (10.90%)  60/594 (10.10%) 
Neutropenia  1  207/587 (35.26%)  209/594 (35.19%) 
Thrombocytopenia  1  20/587 (3.41%)  39/594 (6.57%) 
Eye disorders     
Conjunctivitis  1  81/587 (13.80%)  11/594 (1.85%) 
Gastrointestinal disorders     
Abdominal pain  1  122/587 (20.78%)  105/594 (17.68%) 
Abdominal pain upper  1  37/587 (6.30%)  33/594 (5.56%) 
Constipation  1  139/587 (23.68%)  125/594 (21.04%) 
Diarrhoea  1  372/587 (63.37%)  321/594 (54.04%) 
Dry mouth  1  30/587 (5.11%)  10/594 (1.68%) 
Dyspepsia  1  40/587 (6.81%)  32/594 (5.39%) 
Nausea  1  276/587 (47.02%)  269/594 (45.29%) 
Stomatitis  1  131/587 (22.32%)  75/594 (12.63%) 
Vomiting  1  154/587 (26.24%)  162/594 (27.27%) 
General disorders     
Asthenia  1  74/587 (12.61%)  81/594 (13.64%) 
Fatigue  1  203/587 (34.58%)  186/594 (31.31%) 
Mucosal inflammation  1  121/587 (20.61%)  68/594 (11.45%) 
Oedema peripheral  1  59/587 (10.05%)  41/594 (6.90%) 
Pain  1  43/587 (7.33%)  29/594 (4.88%) 
Pyrexia  1  105/587 (17.89%)  89/594 (14.98%) 
Infections and infestations     
Paronychia  1  102/587 (17.38%)  3/594 (0.51%) 
Investigations     
Weight decreased  1  60/587 (10.22%)  29/594 (4.88%) 
Metabolism and nutrition disorders     
Anorexia  1  146/587 (24.87%)  93/594 (15.66%) 
Hypocalcaemia  1  32/587 (5.45%)  9/594 (1.52%) 
Hypokalaemia  1  65/587 (11.07%)  27/594 (4.55%) 
Hypomagnesaemia  1  120/587 (20.44%)  15/594 (2.53%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  62/587 (10.56%)  44/594 (7.41%) 
Nervous system disorders     
Dizziness  1  36/587 (6.13%)  35/594 (5.89%) 
Headache  1  34/587 (5.79%)  40/594 (6.73%) 
Psychiatric disorders     
Insomnia  1  53/587 (9.03%)  48/594 (8.08%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  42/587 (7.16%)  55/594 (9.26%) 
Dyspnoea  1  54/587 (9.20%)  36/594 (6.06%) 
Epistaxis  1  52/587 (8.86%)  38/594 (6.40%) 
Skin and subcutaneous tissue disorders     
Acne  1  80/587 (13.63%)  10/594 (1.68%) 
Alopecia  1  124/587 (21.12%)  136/594 (22.90%) 
Dermatitis acneiform  1  141/587 (24.02%)  3/594 (0.51%) 
Dry skin  1  129/587 (21.98%)  23/594 (3.87%) 
Erythema  1  92/587 (15.67%)  16/594 (2.69%) 
Nail disorder  1  43/587 (7.33%)  8/594 (1.35%) 
Palmar-plantar erythrodysaesthesia syndrome  1  54/587 (9.20%)  22/594 (3.70%) 
Pruritus  1  107/587 (18.23%)  18/594 (3.03%) 
Rash  1  330/587 (56.22%)  38/594 (6.40%) 
Skin fissures  1  94/587 (16.01%)  3/594 (0.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00339183    
Other Study ID Numbers: 20050181
First Submitted: June 16, 2006
First Posted: June 20, 2006
Results First Submitted: April 3, 2014
Results First Posted: May 6, 2014
Last Update Posted: September 23, 2022