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Trial record 2 of 5 for:    24024839 [PUBMED-IDS]

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

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ClinicalTrials.gov Identifier: NCT00364013
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : March 28, 2014
Last Update Posted : August 12, 2019
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: FOLFOX regimen
Enrollment 1183
Recruitment Details

First patient enrolled 23 August 2006 and last patient enrolled 01 February 2008.

Participant flow data are reported as of the data cut-off date of 28 August 2009.

Pre-assignment Details  
Arm/Group Title FOLFOX + Panitumumab FOLFOX Alone
Hide Arm/Group Description Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Period Title: Overall Study
Started 593 590
Received Study Drug 586 [1] 583
Completed 492 [2] 495 [2]
Not Completed 101 95
Reason Not Completed
Ineligibility determined             4             2
Adverse Event             4             3
Withdrawal by Subject             13             18
Physician Decision             3             3
Lost to Follow-up             10             3
Protocol-specified criteria             6             6
Other             41             47
Ongoing             20             13
[1]
One participant randomized to this group did not receive any panitumumab
[2]
Indicates participants who had completed the safety visit 30 days after last dose or had died
Arm/Group Title FOLFOX + Panitumumab FOLFOX Alone Total
Hide Arm/Group Description Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 593 590 1183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 593 participants 590 participants 1183 participants
61.5  (10.1) 60.3  (11.0) 60.9  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 593 participants 590 participants 1183 participants
Female
207
  34.9%
232
  39.3%
439
  37.1%
Male
386
  65.1%
358
  60.7%
744
  62.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 590 participants 1183 participants
White or Caucasian 530 540 1070
Black or African American 8 15 23
Hispanic or Latino 42 26 68
Asian 8 4 12
Other 5 5 10
Geographic Region   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 590 participants 1183 participants
Western Europe, Canada and Australia 332 329 661
Rest of world 261 261 522
[1]
Measure Description: Stratification factor. Rest of world includes South America, eastern Europe, South Africa and Mexico
KRAS Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 590 participants 1183 participants
Wild-type KRAS 325 331 656
Mutant KRAS 221 219 440
Unevaluable KRAS 47 40 87
[1]
Measure Description: KRAS, the human homolog of the Kirsten rat sarcoma-2 virus oncogene
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 590 participants 1183 participants
Grade 0 332 320 652
Grade 1 230 238 468
Grade 2 31 29 60
Grade 3 0 0 0
Grade 4 0 1 1
Mising/Unknown 0 2 2
[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
Primary tumor type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 590 participants 1183 participants
Colon cancer 394 398 792
Rectal cancer 199 192 391
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. 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 cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.
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 - FOLFOX + Panitumumab Wild-type KRAS - FOLFOX Mutant KRAS - FOLFOX + Panitumumab Mutant KRAS - FOLFOX
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 325 331 221 219
Median (95% Confidence Interval)
Unit of Measure: months
9.6
(9.2 to 11.1)
8.0
(7.5 to 9.3)
7.3
(6.3 to 8.0)
8.8
(7.7 to 9.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wild-type KRAS - FOLFOX + Panitumumab, Wild-type KRAS - FOLFOX
Comments PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0234
Comments P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Normal score
Estimated Value -2.27
Estimation Comments A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mutant KRAS - FOLFOX + Panitumumab, Mutant KRAS - FOLFOX
Comments PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0227
Comments P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Normal score
Estimated Value 2.28
Estimation Comments A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.
2.Secondary Outcome
Title Overall Survival
Hide Description The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.
Time Frame From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Efficacy Analysis Set
Arm/Group Title Wild-type KRAS - FOLFOX + Panitumumab Wild-type KRAS - FOLFOX Mutant KRAS - FOLFOX + Panitumumab Mutant KRAS - FOLFOX
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 325 331 221 219
Median (95% Confidence Interval)
Unit of Measure: months
23.9
(20.3 to 28.3)
19.7
(17.6 to 22.6)
15.5
(13.1 to 17.6)
19.3
(16.5 to 21.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wild-type KRAS - FOLFOX + Panitumumab, Wild-type KRAS - FOLFOX
Comments Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0723
Comments cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Normal score
Estimated Value -1.80
Estimation Comments A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mutant KRAS - FOLFOX + Panitumumab, Mutant KRAS - FOLFOX
Comments Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0678
Comments P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Normal score
Estimated Value 1.83
Estimation Comments A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX 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 by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, 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 September 2008; Maximum follow-up time was 109 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Evaluable 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).
Arm/Group Title Wild-type KRAS - FOLFOX + Panitumumab Wild-type KRAS - FOLFOX Mutant KRAS - FOLFOX + Panitumumab Mutant KRAS - FOLFOX
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 317 323 215 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.21
(49.55 to 60.77)
47.68
(42.12 to 53.28)
39.53
(32.95 to 46.41)
40.28
(33.61 to 47.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wild-type KRAS - FOLFOX + Panitumumab, Wild-type KRAS - FOLFOX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0684
Comments [Not Specified]
Method Stratified exact test
Comments Adjusted for geographic region and ECOG score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
0.98 to 1.87
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 FOLFOX alone arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mutant KRAS - FOLFOX + Panitumumab, Mutant KRAS - FOLFOX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9822
Comments [Not Specified]
Method Stratified exact test
Comments Adjusted for geographic region and ECOG score
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.65 to 1.47
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 FOLFOX alone arm.
4.Secondary Outcome
Title Time to Progression
Hide Description Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.
Time Frame From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Efficacy Analysis Set
Arm/Group Title Wild-type KRAS - FOLFOX + Panitumumab Wild-type KRAS - FOLFOX Mutant KRAS - FOLFOX + Panitumumab Mutant KRAS - FOLFOX
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 325 331 221 219
Median (95% Confidence Interval)
Unit of Measure: months
10.8
(9.4 to 12.4)
9.2
(7.7 to 9.9)
7.5
(7.2 to 8.9)
9.0
(7.7 to 9.5)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.
Time Frame Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
KRAS Evaluable Central Tumor Response Analysis Set: Responders
Arm/Group Title Wild-type KRAS - FOLFOX + Panitumumab Wild-type KRAS - FOLFOX Mutant KRAS - FOLFOX + Panitumumab Mutant KRAS - FOLFOX
Hide Arm/Group Description:
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 175 154 85 85
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(9.5 to 13.0)
8.8
(7.8 to 9.7)
7.4
(5.9 to 8.3)
8.0
(6.5 to 9.5)
6.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • 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 28 August 2009; Maximum time on follow-up was 153 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX’, but received ‘FOLFOX Alone’ so is counted in that group.
Arm/Group Title FOLFOX + Panitumumab FOLFOX Alone
Hide Arm/Group Description:
Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Overall Number of Participants Analyzed 585 584
Measure Type: Number
Unit of Measure: participants
Any adverse event 583 579
Serious adverse event 262 198
Leading to discontinuation of any study drug 136 84
Treatment-related adverse event (TRAE) 581 565
Serious treatment-related adverse event 162 89
TRAE leading to discontinuation of any study drug 117 63
Time Frame The median treatment period was around 7.7 months in the Panitumumab arm, and around 6.7 months in the Chemo alone arm.
Adverse Event Reporting Description

One participant was randomized to 'Panitumumab Plus FOLFOX’, but received ‘FOLFOX Alone’ so is counted in that group.

The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.

 
Arm/Group Title Panitumumab Plus FOLFOX FOLFOX Alone
Hide Arm/Group Description Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
All-Cause Mortality
Panitumumab Plus FOLFOX FOLFOX Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panitumumab Plus FOLFOX FOLFOX Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   262/585 (44.79%)   198/584 (33.90%) 
Blood and lymphatic system disorders     
Anaemia  1  8/585 (1.37%)  3/584 (0.51%) 
Febrile neutropenia  1  15/585 (2.56%)  14/584 (2.40%) 
Hyperviscosity syndrome  1  0/585 (0.00%)  1/584 (0.17%) 
Idiopathic thrombocytopenic purpura  1  1/585 (0.17%)  0/584 (0.00%) 
Leukopenia  1  2/585 (0.34%)  1/584 (0.17%) 
Neutropenia  1  11/585 (1.88%)  10/584 (1.71%) 
Splenic lesion  1  1/585 (0.17%)  0/584 (0.00%) 
Thrombocytopenia  1  4/585 (0.68%)  2/584 (0.34%) 
Cardiac disorders     
Acute myocardial infarction  1  0/585 (0.00%)  2/584 (0.34%) 
Angina pectoris  1  0/585 (0.00%)  1/584 (0.17%) 
Angina unstable  1  1/585 (0.17%)  0/584 (0.00%) 
Atrial fibrillation  1  3/585 (0.51%)  1/584 (0.17%) 
Cardiac failure congestive  1  0/585 (0.00%)  1/584 (0.17%) 
Cardio-respiratory arrest  1  2/585 (0.34%)  1/584 (0.17%) 
Cardiogenic shock  1  1/585 (0.17%)  0/584 (0.00%) 
Myocardial infarction  1  1/585 (0.17%)  0/584 (0.00%) 
Myocardial ischaemia  1  0/585 (0.00%)  1/584 (0.17%) 
Tachycardia  1  1/585 (0.17%)  0/584 (0.00%) 
Ventricular arrhythmia  1  1/585 (0.17%)  0/584 (0.00%) 
Ventricular fibrillation  1  0/585 (0.00%)  1/584 (0.17%) 
Congenital, familial and genetic disorders     
Gilbert's syndrome  1  1/585 (0.17%)  0/584 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/585 (0.00%)  1/584 (0.17%) 
Eye disorders     
Amaurosis fugax  1  0/585 (0.00%)  1/584 (0.17%) 
Conjunctivitis  1  1/585 (0.17%)  0/584 (0.00%) 
Trichiasis  1  1/585 (0.17%)  0/584 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  14/585 (2.39%)  10/584 (1.71%) 
Abdominal pain upper  1  2/585 (0.34%)  1/584 (0.17%) 
Anal erosion  1  1/585 (0.17%)  0/584 (0.00%) 
Anal fistula  1  1/585 (0.17%)  0/584 (0.00%) 
Anal haemorrhage  1  1/585 (0.17%)  0/584 (0.00%) 
Anorectal disorder  1  1/585 (0.17%)  0/584 (0.00%) 
Ascites  1  2/585 (0.34%)  0/584 (0.00%) 
Colonic obstruction  1  0/585 (0.00%)  1/584 (0.17%) 
Colonic stenosis  1  1/585 (0.17%)  0/584 (0.00%) 
Constipation  1  1/585 (0.17%)  1/584 (0.17%) 
Dental caries  1  1/585 (0.17%)  0/584 (0.00%) 
Diarrhoea  1  58/585 (9.91%)  17/584 (2.91%) 
Dry mouth  1  1/585 (0.17%)  0/584 (0.00%) 
Dysphagia  1  1/585 (0.17%)  0/584 (0.00%) 
Enterovesical fistula  1  0/585 (0.00%)  1/584 (0.17%) 
Faecal incontinence  1  0/585 (0.00%)  1/584 (0.17%) 
Faecalith  1  1/585 (0.17%)  0/584 (0.00%) 
Gastric dilatation  1  1/585 (0.17%)  0/584 (0.00%) 
Gastric haemorrhage  1  1/585 (0.17%)  0/584 (0.00%) 
Gastrointestinal haemorrhage  1  5/585 (0.85%)  0/584 (0.00%) 
Gastrointestinal inflammation  1  1/585 (0.17%)  0/584 (0.00%) 
Gastrointestinal perforation  1  0/585 (0.00%)  1/584 (0.17%) 
Haematemesis  1  0/585 (0.00%)  2/584 (0.34%) 
Haemorrhoidal haemorrhage  1  0/585 (0.00%)  1/584 (0.17%) 
Haemorrhoids  1  0/585 (0.00%)  1/584 (0.17%) 
Ileus  1  6/585 (1.03%)  1/584 (0.17%) 
Inguinal hernia  1  1/585 (0.17%)  1/584 (0.17%) 
Intestinal ischaemia  1  1/585 (0.17%)  0/584 (0.00%) 
Intestinal obstruction  1  18/585 (3.08%)  12/584 (2.05%) 
Intestinal perforation  1  3/585 (0.51%)  1/584 (0.17%) 
Intestinal prolapse  1  0/585 (0.00%)  1/584 (0.17%) 
Intra-abdominal haemorrhage  1  1/585 (0.17%)  0/584 (0.00%) 
Large intestinal obstruction  1  1/585 (0.17%)  0/584 (0.00%) 
Large intestine perforation  1  1/585 (0.17%)  1/584 (0.17%) 
Mechanical ileus  1  1/585 (0.17%)  0/584 (0.00%) 
Melaena  1  0/585 (0.00%)  1/584 (0.17%) 
Nausea  1  12/585 (2.05%)  3/584 (0.51%) 
Obstruction gastric  1  1/585 (0.17%)  0/584 (0.00%) 
Oesophagitis  1  1/585 (0.17%)  0/584 (0.00%) 
Peritonitis  1  0/585 (0.00%)  1/584 (0.17%) 
Rectal haemorrhage  1  2/585 (0.34%)  2/584 (0.34%) 
Rectal perforation  1  1/585 (0.17%)  0/584 (0.00%) 
Retroperitoneal oedema  1  0/585 (0.00%)  1/584 (0.17%) 
Small intestinal obstruction  1  4/585 (0.68%)  5/584 (0.86%) 
Stomatitis  1  4/585 (0.68%)  0/584 (0.00%) 
Subileus  1  0/585 (0.00%)  2/584 (0.34%) 
Upper gastrointestinal haemorrhage  1  1/585 (0.17%)  0/584 (0.00%) 
Vomiting  1  18/585 (3.08%)  12/584 (2.05%) 
General disorders     
Asthenia  1  6/585 (1.03%)  2/584 (0.34%) 
Catheter related complication  1  1/585 (0.17%)  0/584 (0.00%) 
Catheter site haemorrhage  1  0/585 (0.00%)  1/584 (0.17%) 
Catheter thrombosis  1  0/585 (0.00%)  3/584 (0.51%) 
Chest pain  1  4/585 (0.68%)  0/584 (0.00%) 
Chills  1  0/585 (0.00%)  3/584 (0.51%) 
Fatigue  1  5/585 (0.85%)  1/584 (0.17%) 
General physical health deterioration  1  7/585 (1.20%)  2/584 (0.34%) 
Hyperpyrexia  1  1/585 (0.17%)  0/584 (0.00%) 
Inflammation of wound  1  1/585 (0.17%)  0/584 (0.00%) 
Infusion site extravasation  1  0/585 (0.00%)  1/584 (0.17%) 
Malaise  1  1/585 (0.17%)  0/584 (0.00%) 
Mucosal inflammation  1  6/585 (1.03%)  2/584 (0.34%) 
Multi-organ failure  1  1/585 (0.17%)  1/584 (0.17%) 
Oedema  1  1/585 (0.17%)  0/584 (0.00%) 
Oedema peripheral  1  1/585 (0.17%)  0/584 (0.00%) 
Pelvic mass  1  0/585 (0.00%)  1/584 (0.17%) 
Performance status decreased  1  0/585 (0.00%)  2/584 (0.34%) 
Pyrexia  1  16/585 (2.74%)  15/584 (2.57%) 
Sudden death  1  1/585 (0.17%)  2/584 (0.34%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/585 (0.17%)  0/584 (0.00%) 
Bile duct stone  1  1/585 (0.17%)  0/584 (0.00%) 
Cholangitis  1  1/585 (0.17%)  0/584 (0.00%) 
Cholecystitis  1  1/585 (0.17%)  1/584 (0.17%) 
Cholecystitis acute  1  0/585 (0.00%)  1/584 (0.17%) 
Cholelithiasis  1  1/585 (0.17%)  0/584 (0.00%) 
Cholestasis  1  0/585 (0.00%)  1/584 (0.17%) 
Hepatic failure  1  3/585 (0.51%)  0/584 (0.00%) 
Hyperbilirubinaemia  1  1/585 (0.17%)  0/584 (0.00%) 
Jaundice  1  2/585 (0.34%)  1/584 (0.17%) 
Portal vein thrombosis  1  0/585 (0.00%)  1/584 (0.17%) 
Immune system disorders     
Drug hypersensitivity  1  2/585 (0.34%)  2/584 (0.34%) 
Hypersensitivity  1  4/585 (0.68%)  4/584 (0.68%) 
Infections and infestations     
Abdominal abscess  1  2/585 (0.34%)  0/584 (0.00%) 
Abdominal sepsis  1  0/585 (0.00%)  1/584 (0.17%) 
Abdominal wall abscess  1  1/585 (0.17%)  0/584 (0.00%) 
Abscess intestinal  1  1/585 (0.17%)  0/584 (0.00%) 
Acne pustular  1  1/585 (0.17%)  0/584 (0.00%) 
Anal abscess  1  1/585 (0.17%)  0/584 (0.00%) 
Bacteraemia  1  2/585 (0.34%)  2/584 (0.34%) 
Biliary abscess  1  1/585 (0.17%)  0/584 (0.00%) 
Biliary sepsis  1  1/585 (0.17%)  0/584 (0.00%) 
Bronchitis  1  0/585 (0.00%)  1/584 (0.17%) 
Bronchopneumonia  1  0/585 (0.00%)  1/584 (0.17%) 
Catheter related infection  1  6/585 (1.03%)  4/584 (0.68%) 
Catheter sepsis  1  0/585 (0.00%)  2/584 (0.34%) 
Cellulitis  1  2/585 (0.34%)  0/584 (0.00%) 
Central line infection  1  1/585 (0.17%)  0/584 (0.00%) 
Conjunctivitis infective  1  1/585 (0.17%)  0/584 (0.00%) 
Cystitis  1  0/585 (0.00%)  1/584 (0.17%) 
Diabetic gangrene  1  0/585 (0.00%)  1/584 (0.17%) 
Folliculitis  1  2/585 (0.34%)  0/584 (0.00%) 
Gastroenteritis  1  2/585 (0.34%)  0/584 (0.00%) 
Groin abscess  1  1/585 (0.17%)  0/584 (0.00%) 
Hepatic infection  1  0/585 (0.00%)  1/584 (0.17%) 
Herpes zoster  1  0/585 (0.00%)  1/584 (0.17%) 
Infection  1  0/585 (0.00%)  1/584 (0.17%) 
Liver abscess  1  0/585 (0.00%)  1/584 (0.17%) 
Lobar pneumonia  1  1/585 (0.17%)  1/584 (0.17%) 
Lower respiratory tract infection  1  0/585 (0.00%)  1/584 (0.17%) 
Lung abscess  1  1/585 (0.17%)  0/584 (0.00%) 
Lung infection  1  0/585 (0.00%)  1/584 (0.17%) 
Necrotising fasciitis  1  0/585 (0.00%)  1/584 (0.17%) 
Neutropenic sepsis  1  1/585 (0.17%)  1/584 (0.17%) 
Oral herpes  1  0/585 (0.00%)  1/584 (0.17%) 
Orchitis  1  1/585 (0.17%)  0/584 (0.00%) 
Pneumonia  1  10/585 (1.71%)  8/584 (1.37%) 
Pneumonia bacterial  1  1/585 (0.17%)  0/584 (0.00%) 
Pneumonia mycoplasmal  1  0/585 (0.00%)  1/584 (0.17%) 
Post procedural infection  1  0/585 (0.00%)  1/584 (0.17%) 
Postoperative wound infection  1  1/585 (0.17%)  0/584 (0.00%) 
Pseudomonal sepsis  1  1/585 (0.17%)  0/584 (0.00%) 
Pyelonephritis  1  2/585 (0.34%)  0/584 (0.00%) 
Respiratory tract infection  1  1/585 (0.17%)  1/584 (0.17%) 
Salmonellosis  1  1/585 (0.17%)  0/584 (0.00%) 
Sepsis  1  12/585 (2.05%)  7/584 (1.20%) 
Septic shock  1  2/585 (0.34%)  2/584 (0.34%) 
Skin infection  1  2/585 (0.34%)  0/584 (0.00%) 
Staphylococcal infection  1  2/585 (0.34%)  0/584 (0.00%) 
Subcutaneous abscess  1  0/585 (0.00%)  1/584 (0.17%) 
Subdiaphragmatic abscess  1  1/585 (0.17%)  1/584 (0.17%) 
Tooth infection  1  2/585 (0.34%)  0/584 (0.00%) 
Upper respiratory tract infection  1  1/585 (0.17%)  0/584 (0.00%) 
Urinary tract infection  1  7/585 (1.20%)  5/584 (0.86%) 
Urinary tract infection viral  1  0/585 (0.00%)  1/584 (0.17%) 
Viral infection  1  0/585 (0.00%)  2/584 (0.34%) 
Injury, poisoning and procedural complications     
Anal injury  1  1/585 (0.17%)  0/584 (0.00%) 
Anastomotic leak  1  1/585 (0.17%)  0/584 (0.00%) 
Device dislocation  1  1/585 (0.17%)  0/584 (0.00%) 
Fall  1  1/585 (0.17%)  1/584 (0.17%) 
Femur fracture  1  0/585 (0.00%)  1/584 (0.17%) 
Gastrointestinal stoma complication  1  0/585 (0.00%)  3/584 (0.51%) 
Hepatic haematoma  1  1/585 (0.17%)  0/584 (0.00%) 
Hip fracture  1  1/585 (0.17%)  1/584 (0.17%) 
Medical device complication  1  1/585 (0.17%)  0/584 (0.00%) 
Post procedural complication  1  2/585 (0.34%)  0/584 (0.00%) 
Procedural pain  1  1/585 (0.17%)  1/584 (0.17%) 
Road traffic accident  1  1/585 (0.17%)  0/584 (0.00%) 
Skin laceration  1  0/585 (0.00%)  1/584 (0.17%) 
Spinal fracture  1  1/585 (0.17%)  0/584 (0.00%) 
Stent occlusion  1  1/585 (0.17%)  0/584 (0.00%) 
Transfusion reaction  1  0/585 (0.00%)  1/584 (0.17%) 
Upper limb fracture  1  1/585 (0.17%)  0/584 (0.00%) 
Investigations     
Blood creatinine increased  1  1/585 (0.17%)  0/584 (0.00%) 
Blood culture positive  1  1/585 (0.17%)  0/584 (0.00%) 
Cardiac enzymes increased  1  1/585 (0.17%)  0/584 (0.00%) 
Weight decreased  1  2/585 (0.34%)  0/584 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  9/585 (1.54%)  2/584 (0.34%) 
Dehydration  1  20/585 (3.42%)  5/584 (0.86%) 
Diabetes mellitus  1  1/585 (0.17%)  2/584 (0.34%) 
Diabetes mellitus inadequate control  1  1/585 (0.17%)  0/584 (0.00%) 
Diabetic ketoacidosis  1  1/585 (0.17%)  0/584 (0.00%) 
Failure to thrive  1  1/585 (0.17%)  0/584 (0.00%) 
Fluid overload  1  0/585 (0.00%)  1/584 (0.17%) 
Hypercalcaemia  1  0/585 (0.00%)  1/584 (0.17%) 
Hyperglycaemia  1  1/585 (0.17%)  1/584 (0.17%) 
Hypoalbuminaemia  1  1/585 (0.17%)  0/584 (0.00%) 
Hypocalcaemia  1  1/585 (0.17%)  0/584 (0.00%) 
Hypoglycaemia  1  1/585 (0.17%)  0/584 (0.00%) 
Hypokalaemia  1  6/585 (1.03%)  0/584 (0.00%) 
Hypomagnesaemia  1  3/585 (0.51%)  0/584 (0.00%) 
Hyponatraemia  1  1/585 (0.17%)  0/584 (0.00%) 
Ketoacidosis  1  0/585 (0.00%)  1/584 (0.17%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/585 (0.68%)  1/584 (0.17%) 
Musculoskeletal pain  1  2/585 (0.34%)  1/584 (0.17%) 
Neck pain  1  1/585 (0.17%)  0/584 (0.00%) 
Osteoporotic fracture  1  1/585 (0.17%)  0/584 (0.00%) 
Pain in extremity  1  1/585 (0.17%)  0/584 (0.00%) 
Rotator cuff syndrome  1  0/585 (0.00%)  1/584 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bone neoplasm  1  1/585 (0.17%)  0/584 (0.00%) 
Cancer pain  1  0/585 (0.00%)  1/584 (0.17%) 
Colorectal cancer metastatic  1  9/585 (1.54%)  5/584 (0.86%) 
Metastases to bone  1  0/585 (0.00%)  1/584 (0.17%) 
Metastases to central nervous system  1  1/585 (0.17%)  1/584 (0.17%) 
Metastases to ovary  1  0/585 (0.00%)  1/584 (0.17%) 
Metastatic neoplasm  1  1/585 (0.17%)  0/584 (0.00%) 
Pelvic neoplasm  1  1/585 (0.17%)  0/584 (0.00%) 
Prostate cancer  1  0/585 (0.00%)  1/584 (0.17%) 
Tumour associated fever  1  0/585 (0.00%)  1/584 (0.17%) 
Tumour haemorrhage  1  0/585 (0.00%)  1/584 (0.17%) 
Tumour local invasion  1  0/585 (0.00%)  1/584 (0.17%) 
Nervous system disorders     
Aphasia  1  1/585 (0.17%)  0/584 (0.00%) 
Ataxia  1  0/585 (0.00%)  1/584 (0.17%) 
Balance disorder  1  0/585 (0.00%)  1/584 (0.17%) 
Cerebral haemorrhage  1  0/585 (0.00%)  1/584 (0.17%) 
Cerebral infarction  1  1/585 (0.17%)  0/584 (0.00%) 
Cerebral ischaemia  1  0/585 (0.00%)  1/584 (0.17%) 
Cerebrovascular accident  1  3/585 (0.51%)  0/584 (0.00%) 
Cerebrovascular insufficiency  1  1/585 (0.17%)  0/584 (0.00%) 
Coma  1  1/585 (0.17%)  0/584 (0.00%) 
Convulsion  1  1/585 (0.17%)  2/584 (0.34%) 
Dysarthria  1  1/585 (0.17%)  0/584 (0.00%) 
Hemiparesis  1  0/585 (0.00%)  1/584 (0.17%) 
Hydrocephalus  1  0/585 (0.00%)  1/584 (0.17%) 
Ischaemic stroke  1  0/585 (0.00%)  1/584 (0.17%) 
Lethargy  1  1/585 (0.17%)  0/584 (0.00%) 
Mental impairment  1  1/585 (0.17%)  0/584 (0.00%) 
Nervous system disorder  1  0/585 (0.00%)  1/584 (0.17%) 
Neuropathy peripheral  1  0/585 (0.00%)  1/584 (0.17%) 
Paraparesis  1  2/585 (0.34%)  0/584 (0.00%) 
Spinal cord compression  1  0/585 (0.00%)  2/584 (0.34%) 
Syncope  1  2/585 (0.34%)  3/584 (0.51%) 
Transient ischaemic attack  1  0/585 (0.00%)  1/584 (0.17%) 
Psychiatric disorders     
Abnormal behaviour  1  0/585 (0.00%)  1/584 (0.17%) 
Confusional state  1  4/585 (0.68%)  1/584 (0.17%) 
Personality disorder  1  0/585 (0.00%)  1/584 (0.17%) 
Renal and urinary disorders     
Calculus ureteric  1  0/585 (0.00%)  1/584 (0.17%) 
Oliguria  1  0/585 (0.00%)  1/584 (0.17%) 
Renal colic  1  1/585 (0.17%)  0/584 (0.00%) 
Renal failure  1  8/585 (1.37%)  6/584 (1.03%) 
Renal failure acute  1  3/585 (0.51%)  1/584 (0.17%) 
Urinary bladder haemorrhage  1  0/585 (0.00%)  1/584 (0.17%) 
Urinary retention  1  0/585 (0.00%)  1/584 (0.17%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/585 (0.17%)  0/584 (0.00%) 
Acute respiratory distress syndrome  1  1/585 (0.17%)  0/584 (0.00%) 
Allergic cough  1  1/585 (0.17%)  0/584 (0.00%) 
Aspiration  1  0/585 (0.00%)  1/584 (0.17%) 
Dyspnoea  1  5/585 (0.85%)  1/584 (0.17%) 
Epistaxis  1  1/585 (0.17%)  0/584 (0.00%) 
Haemoptysis  1  1/585 (0.17%)  0/584 (0.00%) 
Hypoxia  1  0/585 (0.00%)  3/584 (0.51%) 
Interstitial lung disease  1  1/585 (0.17%)  0/584 (0.00%) 
Laryngospasm  1  0/585 (0.00%)  1/584 (0.17%) 
Oropharyngeal pain  1  0/585 (0.00%)  1/584 (0.17%) 
Pleural effusion  1  2/585 (0.34%)  0/584 (0.00%) 
Pneumonitis  1  1/585 (0.17%)  1/584 (0.17%) 
Pneumothorax  1  3/585 (0.51%)  3/584 (0.51%) 
Pulmonary artery thrombosis  1  1/585 (0.17%)  0/584 (0.00%) 
Pulmonary embolism  1  14/585 (2.39%)  10/584 (1.71%) 
Pulmonary fibrosis  1  0/585 (0.00%)  1/584 (0.17%) 
Pulmonary infarction  1  1/585 (0.17%)  0/584 (0.00%) 
Pulmonary thrombosis  1  0/585 (0.00%)  1/584 (0.17%) 
Respiratory arrest  1  0/585 (0.00%)  2/584 (0.34%) 
Respiratory failure  1  1/585 (0.17%)  0/584 (0.00%) 
Wheezing  1  1/585 (0.17%)  0/584 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  2/585 (0.34%)  0/584 (0.00%) 
Dermatitis acneiform  1  2/585 (0.34%)  0/584 (0.00%) 
Dermatitis allergic  1  1/585 (0.17%)  1/584 (0.17%) 
Dermatosis  1  1/585 (0.17%)  0/584 (0.00%) 
Hyperhidrosis  1  0/585 (0.00%)  1/584 (0.17%) 
Pruritus allergic  1  0/585 (0.00%)  1/584 (0.17%) 
Rash  1  10/585 (1.71%)  2/584 (0.34%) 
Rash pruritic  1  1/585 (0.17%)  0/584 (0.00%) 
Skin exfoliation  1  1/585 (0.17%)  0/584 (0.00%) 
Skin toxicity  1  1/585 (0.17%)  0/584 (0.00%) 
Swelling face  1  1/585 (0.17%)  0/584 (0.00%) 
Toxic skin eruption  1  1/585 (0.17%)  0/584 (0.00%) 
Surgical and medical procedures     
Catheter placement  1  1/585 (0.17%)  0/584 (0.00%) 
Vascular disorders     
Arterial thrombosis limb  1  0/585 (0.00%)  1/584 (0.17%) 
Axillary vein thrombosis  1  0/585 (0.00%)  1/584 (0.17%) 
Circulatory collapse  1  1/585 (0.17%)  0/584 (0.00%) 
Deep vein thrombosis  1  9/585 (1.54%)  5/584 (0.86%) 
Embolism  1  1/585 (0.17%)  1/584 (0.17%) 
Embolism venous  1  1/585 (0.17%)  0/584 (0.00%) 
Hypotension  1  4/585 (0.68%)  2/584 (0.34%) 
Iliac artery embolism  1  1/585 (0.17%)  0/584 (0.00%) 
Peripheral embolism  1  1/585 (0.17%)  0/584 (0.00%) 
Subclavian vein thrombosis  1  1/585 (0.17%)  1/584 (0.17%) 
Thrombophlebitis  1  1/585 (0.17%)  1/584 (0.17%) 
Thrombosis  1  0/585 (0.00%)  1/584 (0.17%) 
Venous thrombosis  1  2/585 (0.34%)  0/584 (0.00%) 
Venous thrombosis limb  1  2/585 (0.34%)  1/584 (0.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab Plus FOLFOX FOLFOX Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   577/585 (98.63%)   571/584 (97.77%) 
Blood and lymphatic system disorders     
Anaemia  1  84/585 (14.36%)  81/584 (13.87%) 
Leukopenia  1  48/585 (8.21%)  50/584 (8.56%) 
Neutropenia  1  315/585 (53.85%)  353/584 (60.45%) 
Thrombocytopenia  1  115/585 (19.66%)  157/584 (26.88%) 
Eye disorders     
Conjunctivitis  1  103/585 (17.61%)  20/584 (3.42%) 
Lacrimation increased  1  26/585 (4.44%)  40/584 (6.85%) 
Gastrointestinal disorders     
Abdominal pain  1  156/585 (26.67%)  133/584 (22.77%) 
Abdominal pain upper  1  49/585 (8.38%)  55/584 (9.42%) 
Constipation  1  154/585 (26.32%)  155/584 (26.54%) 
Diarrhoea  1  349/585 (59.66%)  282/584 (48.29%) 
Dry mouth  1  31/585 (5.30%)  17/584 (2.91%) 
Dyspepsia  1  64/585 (10.94%)  63/584 (10.79%) 
Nausea  1  261/585 (44.62%)  287/584 (49.14%) 
Stomatitis  1  138/585 (23.59%)  77/584 (13.18%) 
Vomiting  1  175/585 (29.91%)  182/584 (31.16%) 
General disorders     
Asthenia  1  132/585 (22.56%)  117/584 (20.03%) 
Fatigue  1  199/585 (34.02%)  197/584 (33.73%) 
Mucosal inflammation  1  143/585 (24.44%)  87/584 (14.90%) 
Oedema peripheral  1  61/585 (10.43%)  47/584 (8.05%) 
Pyrexia  1  170/585 (29.06%)  149/584 (25.51%) 
Infections and infestations     
Nasopharyngitis  1  31/585 (5.30%)  25/584 (4.28%) 
Paronychia  1  120/585 (20.51%)  0/584 (0.00%) 
Urinary tract infection  1  35/585 (5.98%)  31/584 (5.31%) 
Investigations     
Weight decreased  1  97/585 (16.58%)  39/584 (6.68%) 
Metabolism and nutrition disorders     
Anorexia  1  199/585 (34.02%)  133/584 (22.77%) 
Dehydration  1  32/585 (5.47%)  8/584 (1.37%) 
Hypocalcaemia  1  30/585 (5.13%)  11/584 (1.88%) 
Hypokalaemia  1  116/585 (19.83%)  73/584 (12.50%) 
Hypomagnesaemia  1  175/585 (29.91%)  39/584 (6.68%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  67/585 (11.45%)  68/584 (11.64%) 
Pain in extremity  1  44/585 (7.52%)  39/584 (6.68%) 
Nervous system disorders     
Dizziness  1  38/585 (6.50%)  39/584 (6.68%) 
Dysaesthesia  1  33/585 (5.64%)  50/584 (8.56%) 
Dysgeusia  1  77/585 (13.16%)  79/584 (13.53%) 
Headache  1  37/585 (6.32%)  72/584 (12.33%) 
Lethargy  1  24/585 (4.10%)  30/584 (5.14%) 
Neuropathy peripheral  1  110/585 (18.80%)  138/584 (23.63%) 
Paraesthesia  1  180/585 (30.77%)  204/584 (34.93%) 
Peripheral sensory neuropathy  1  77/585 (13.16%)  89/584 (15.24%) 
Psychiatric disorders     
Anxiety  1  44/585 (7.52%)  31/584 (5.31%) 
Depression  1  34/585 (5.81%)  25/584 (4.28%) 
Insomnia  1  80/585 (13.68%)  82/584 (14.04%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  54/585 (9.23%)  84/584 (14.38%) 
Dyspnoea  1  50/585 (8.55%)  40/584 (6.85%) 
Epistaxis  1  79/585 (13.50%)  53/584 (9.08%) 
Skin and subcutaneous tissue disorders     
Acne  1  74/585 (12.65%)  2/584 (0.34%) 
Alopecia  1  80/585 (13.68%)  56/584 (9.59%) 
Dermatitis acneiform  1  188/585 (32.14%)  2/584 (0.34%) 
Dry skin  1  120/585 (20.51%)  20/584 (3.42%) 
Erythema  1  94/585 (16.07%)  22/584 (3.77%) 
Nail disorder  1  49/585 (8.38%)  11/584 (1.88%) 
Palmar-plantar erythrodysaesthesia syndrome  1  55/585 (9.40%)  21/584 (3.60%) 
Pruritus  1  128/585 (21.88%)  26/584 (4.45%) 
Rash  1  305/585 (52.14%)  39/584 (6.68%) 
Skin fissures  1  89/585 (15.21%)  2/584 (0.34%) 
Vascular disorders     
Hypertension  1  26/585 (4.44%)  36/584 (6.16%) 
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
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00364013     History of Changes
Other Study ID Numbers: 20050203
First Submitted: August 10, 2006
First Posted: August 15, 2006
Results First Submitted: February 13, 2014
Results First Posted: March 28, 2014
Last Update Posted: August 12, 2019