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Trial record 59 of 179 for:    colon cancer | ( Map: New Jersey, United States )

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

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ClinicalTrials.gov Identifier: NCT00819780
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : August 6, 2014
Last Update Posted : August 29, 2018
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
Conditions Colon Cancer
Colorectal Cancer
Rectal Cancer
Metastatic Colorectal Cancer
Interventions Drug: Panitumumab
Drug: Bevacizumab
Drug: mFOLFOX6
Enrollment 285
Recruitment Details First patient was enrolled on 24 April 2009; last patient was enrolled on 09 December 2011.
Pre-assignment Details  
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death. Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Period Title: Overall Study
Started 142 143
Received Study Treatment 139 139
Completed 114 [1] 122 [1]
Not Completed 28 21
Reason Not Completed
Did not receive study drug             3             4
Still in treatment             25             17
[1]
Indicates participants who ended study treatment
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6 Total
Hide Arm/Group Description Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 142 143 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants 143 participants 285 participants
61.6  (10.4) 60.5  (9.8) 61.0  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
Female
56
  39.4%
47
  32.9%
103
  36.1%
Male
86
  60.6%
96
  67.1%
182
  63.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
White or Caucasian 131 127 258
Black or African American 9 6 15
Hispanic or Latino 2 5 7
Asian 0 4 4
Japanese 0 1 1
Prior Adjuvant Oxaliplatin Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
Yes 14 14 28
No 128 129 257
RAS and BRAF Mutation Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 142 participants 143 participants 285 participants
BRAF wild-type 103 108 211
RAS Wild-type 88 82 170
RAS/BRAF wild-type 77 79 156
Testing not performed 13 18 31
Sample acceptance failure 8 7 15
[1]
Measure Description: This analysis was performed on tumors from 136 and 137 participants in each treatment group respectively. BRAF = v-raf murine sarcoma viral oncogene homolog B1; RAS = rat sarcoma viral oncogene homolog, and includes Kirsten rat sarcoma-2 viral oncogene (KRAS) exons 2, 3 & 4 and neuroblastoma RAS viral (v-ras) oncogene (NRAS) exons 2, 3, and 4. Participants may appear in more than one category.
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set (all randomized participants)
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 142 143
Median (95% Confidence Interval)
Unit of Measure: months
10.9
(9.4 to 13.0)
10.1
(9.0 to 12.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3531
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.871
Confidence Interval (2-Sided) 95%
0.651 to 1.166
Estimation Comments A hazard ratio < 1.0 favors panitumumab
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 142 143
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(28.8 to NA)
25.4
(22.9 to 29.5)
[1]
Not estimable due to the low number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1386
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.723
Confidence Interval (2-Sided) 95%
0.470 to 1.111
Estimation Comments A hazard ratio < 1.0 favors panitumumab
3.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 142 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.75
(49.18 to 65.98)
53.52
(44.97 to 61.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5497
Comments [Not Specified]
Method Stratified exact test
Comments Stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.72 to 1.95
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.
4.Secondary Outcome
Title Duration of Response
Hide Description For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for Local Tumor Response Analysis Set: Responders
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 82 76
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(8.4 to 12.9)
9.0
(7.4 to 9.5)
5.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 142 143
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(9.7 to 13.1)
11.1
(9.3 to 12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3861
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.874
Confidence Interval (2-Sided) 95%
0.645 to 1.185
Estimation Comments A hazard ratio < 1.0 favors panitumumab
6.Secondary Outcome
Title Time to Initial Objective Response
Hide Description For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator’s review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for Local Tumor Response Analysis Set: Responders
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 82 76
Median (Inter-Quartile Range)
Unit of Measure: months
1.8
(1.7 to 2.3)
1.9
(1.7 to 3.7)
7.Secondary Outcome
Title Resection Rate
Hide Description The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 142 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.68
(7.69 to 19.29)
11.19
(6.53 to 17.53)
8.Secondary Outcome
Title Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)
Hide Description PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 88 82
Median (95% Confidence Interval)
Unit of Measure: months
13.0
(10.9 to 15.1)
9.5
(9.0 to 12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0286
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.651
Confidence Interval (2-Sided) 95%
0.444 to 0.956
Estimation Comments A hazard ratio < 1.0 favors panitumumab
9.Secondary Outcome
Title Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)
Hide Description PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 77 79
Median (95% Confidence Interval)
Unit of Measure: months
13.1
(10.9 to 15.8)
9.7
(7.9 to 12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0083
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.579
Confidence Interval (2-Sided) 95%
0.386 to 0.869
Estimation Comments A hazard ratio < 1.0 favors panitumumab
10.Secondary Outcome
Title Overall Survival in Participants With Wild-type RAS
Hide Description Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 88 82
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(28.8 to NA)
29.0 [1] 
(24.3 to NA)
[1]
Could not be estimated due to the low number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0934
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.606
Confidence Interval (2-Sided) 95%
0.337 to 1.088
Estimation Comments A hazard ratio < 1.0 favors panitumumab
11.Secondary Outcome
Title Overall Survival in Participants With Wild-type RAS / BRAF
Hide Description Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 77 79
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
29.0 [1] 
(24.3 to NA)
[1]
Could not be estimated due to the low number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method Stratified Cox proportional hazards
Comments The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.465
Confidence Interval (2-Sided) 95%
0.239 to 0.902
Estimation Comments A hazard ratio < 1.0 favors panitumumab
12.Secondary Outcome
Title Percentage of Participants With an Objective Response for Participants With Wild-type RAS
Hide Description

Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.

Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.

Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 88 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.64
(52.69 to 73.63)
60.49
(49.01 to 71.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9426
Comments [Not Specified]
Method Stratified exact test
Comments Stratified by prior exposure to oxaliplatin
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.55 to 2.12
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.
13.Secondary Outcome
Title Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF
Hide Description Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.
Time Frame From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 77 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.64
(51.88 to 74.30)
61.54
(49.83 to 72.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus mFOLFOX6, Bevacizumab Plus mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Stratified exact test
Comments Stratified by prior exposure to oxaliplatin
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.52 to 2.15
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.
14.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.
Time Frame The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6).
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description:
Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
Overall Number of Participants Analyzed 139 139
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 139 139
AE with worst grade of 3 88 78
AE with worst grade of 4 31 28
AE with worst grade of 5 7 9
Serious adverse event (SAE) 61 53
AE leading to discontinuation of study drug 34 37
Any treatment-related adverse event (TRAE) 138 136
Treatment-related AE with worst grade of 3 92 77
Treatment-related AE with worst grade of 4 24 25
Treatment-related AE with worst grade of 5 3 2
Serious treatment-related adverse event 37 28
TRAE leading to discontinuation of study drug 28 29
Time Frame The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus Chemotherapy arm and 7.3 months for Bevacizumab Plus Chemotherapy arm.
Adverse Event Reporting Description The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
 
Arm/Group Title Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Hide Arm/Group Description Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle. Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
All-Cause Mortality
Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Affected / at Risk (%) Affected / at Risk (%)
Total   61/139 (43.88%)   53/139 (38.13%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  3/139 (2.16%)  3/139 (2.16%) 
Leukopenia  1  1/139 (0.72%)  1/139 (0.72%) 
Neutropenia  1  2/139 (1.44%)  2/139 (1.44%) 
Cardiac disorders     
Acute coronary syndrome  1  1/139 (0.72%)  0/139 (0.00%) 
Cardiac arrest  1  1/139 (0.72%)  1/139 (0.72%) 
Cardio-respiratory arrest  1  0/139 (0.00%)  1/139 (0.72%) 
Myocardial infarction  1  0/139 (0.00%)  2/139 (1.44%) 
Gastrointestinal disorders     
Abdominal pain  1  0/139 (0.00%)  2/139 (1.44%) 
Anal fistula  1  0/139 (0.00%)  2/139 (1.44%) 
Colitis  1  1/139 (0.72%)  0/139 (0.00%) 
Constipation  1  2/139 (1.44%)  0/139 (0.00%) 
Diarrhoea  1  9/139 (6.47%)  1/139 (0.72%) 
Gastritis  1  0/139 (0.00%)  1/139 (0.72%) 
Gastrointestinal disorder  1  1/139 (0.72%)  0/139 (0.00%) 
Gastrointestinal perforation  1  0/139 (0.00%)  2/139 (1.44%) 
Gastrooesophageal reflux disease  1  2/139 (1.44%)  0/139 (0.00%) 
Ileus  1  1/139 (0.72%)  3/139 (2.16%) 
Inguinal hernia  1  0/139 (0.00%)  1/139 (0.72%) 
Intestinal obstruction  1  2/139 (1.44%)  2/139 (1.44%) 
Intestinal perforation  1  0/139 (0.00%)  2/139 (1.44%) 
Large intestinal obstruction  1  0/139 (0.00%)  1/139 (0.72%) 
Melaena  1  1/139 (0.72%)  0/139 (0.00%) 
Nausea  1  1/139 (0.72%)  0/139 (0.00%) 
Oesophagitis  1  1/139 (0.72%)  0/139 (0.00%) 
Rectal perforation  1  1/139 (0.72%)  0/139 (0.00%) 
Small intestinal perforation  1  0/139 (0.00%)  1/139 (0.72%) 
Stomatitis  1  2/139 (1.44%)  0/139 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/139 (0.00%)  1/139 (0.72%) 
Vomiting  1  1/139 (0.72%)  2/139 (1.44%) 
General disorders     
Adverse drug reaction  1  1/139 (0.72%)  0/139 (0.00%) 
Chills  1  0/139 (0.00%)  1/139 (0.72%) 
Fatigue  1  1/139 (0.72%)  0/139 (0.00%) 
General physical health deterioration  1  1/139 (0.72%)  0/139 (0.00%) 
Mucosal inflammation  1  1/139 (0.72%)  0/139 (0.00%) 
Non-cardiac chest pain  1  0/139 (0.00%)  2/139 (1.44%) 
Pyrexia  1  2/139 (1.44%)  4/139 (2.88%) 
Thrombosis in device  1  1/139 (0.72%)  0/139 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/139 (0.00%)  1/139 (0.72%) 
Hypersensitivity  1  1/139 (0.72%)  0/139 (0.00%) 
Infections and infestations     
Anal abscess  1  0/139 (0.00%)  1/139 (0.72%) 
Device related sepsis  1  1/139 (0.72%)  0/139 (0.00%) 
Endocarditis  1  0/139 (0.00%)  1/139 (0.72%) 
Escherichia bacteraemia  1  1/139 (0.72%)  0/139 (0.00%) 
Herpes zoster oticus  1  0/139 (0.00%)  1/139 (0.72%) 
Infection  1  0/139 (0.00%)  2/139 (1.44%) 
Infusion site infection  1  1/139 (0.72%)  0/139 (0.00%) 
Meningoencephalitis herpetic  1  0/139 (0.00%)  1/139 (0.72%) 
Orchitis  1  1/139 (0.72%)  0/139 (0.00%) 
Perirectal abscess  1  1/139 (0.72%)  0/139 (0.00%) 
Peritonitis  1  0/139 (0.00%)  1/139 (0.72%) 
Pneumonia  1  2/139 (1.44%)  3/139 (2.16%) 
Postoperative wound infection  1  1/139 (0.72%)  0/139 (0.00%) 
Sepsis  1  3/139 (2.16%)  2/139 (1.44%) 
Septic shock  1  0/139 (0.00%)  1/139 (0.72%) 
Subcutaneous abscess  1  0/139 (0.00%)  1/139 (0.72%) 
Urinary tract infection  1  1/139 (0.72%)  2/139 (1.44%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/139 (0.00%)  1/139 (0.72%) 
Face injury  1  0/139 (0.00%)  1/139 (0.72%) 
Subdural haematoma  1  0/139 (0.00%)  1/139 (0.72%) 
Toxicity to various agents  1  1/139 (0.72%)  0/139 (0.00%) 
Wound haemorrhage  1  0/139 (0.00%)  1/139 (0.72%) 
Investigations     
Eastern Cooperative Oncology Group performance status worsened  1  0/139 (0.00%)  1/139 (0.72%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/139 (0.72%)  0/139 (0.00%) 
Dehydration  1  3/139 (2.16%)  0/139 (0.00%) 
Hypercalcaemia  1  0/139 (0.00%)  1/139 (0.72%) 
Hyperglycaemia  1  0/139 (0.00%)  2/139 (1.44%) 
Hyperkalaemia  1  1/139 (0.72%)  0/139 (0.00%) 
Hypokalaemia  1  1/139 (0.72%)  0/139 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/139 (0.72%)  0/139 (0.00%) 
Groin pain  1  0/139 (0.00%)  1/139 (0.72%) 
Musculoskeletal pain  1  0/139 (0.00%)  1/139 (0.72%) 
Trismus  1  1/139 (0.72%)  0/139 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colorectal cancer  1  1/139 (0.72%)  0/139 (0.00%) 
Nervous system disorders     
Convulsion  1  1/139 (0.72%)  0/139 (0.00%) 
Syncope  1  0/139 (0.00%)  4/139 (2.88%) 
Transient ischaemic attack  1  0/139 (0.00%)  1/139 (0.72%) 
Vertebrobasilar insufficiency  1  0/139 (0.00%)  1/139 (0.72%) 
Psychiatric disorders     
Mood altered  1  0/139 (0.00%)  1/139 (0.72%) 
Panic attack  1  0/139 (0.00%)  1/139 (0.72%) 
Substance abuse  1  1/139 (0.72%)  0/139 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/139 (0.72%)  1/139 (0.72%) 
Renal failure acute  1  1/139 (0.72%)  1/139 (0.72%) 
Ureteric obstruction  1  1/139 (0.72%)  1/139 (0.72%) 
Reproductive system and breast disorders     
Epididymitis  1  1/139 (0.72%)  0/139 (0.00%) 
Pelvic pain  1  0/139 (0.00%)  1/139 (0.72%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/139 (0.72%)  0/139 (0.00%) 
Pneumonia aspiration  1  1/139 (0.72%)  0/139 (0.00%) 
Pulmonary embolism  1  7/139 (5.04%)  6/139 (4.32%) 
Pulmonary venous thrombosis  1  0/139 (0.00%)  1/139 (0.72%) 
Respiratory failure  1  1/139 (0.72%)  0/139 (0.00%) 
Skin and subcutaneous tissue disorders     
Nail bed inflammation  1  1/139 (0.72%)  0/139 (0.00%) 
Rash  1  1/139 (0.72%)  0/139 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  4/139 (2.88%)  4/139 (2.88%) 
Intra-abdominal haematoma  1  0/139 (0.00%)  1/139 (0.72%) 
Jugular vein thrombosis  1  0/139 (0.00%)  1/139 (0.72%) 
Superior vena cava syndrome  1  1/139 (0.72%)  0/139 (0.00%) 
Thrombophlebitis superficial  1  1/139 (0.72%)  0/139 (0.00%) 
Thrombosis  1  0/139 (0.00%)  1/139 (0.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab Plus mFOLFOX6 Bevacizumab Plus mFOLFOX6
Affected / at Risk (%) Affected / at Risk (%)
Total   139/139 (100.00%)   139/139 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  24/139 (17.27%)  20/139 (14.39%) 
Leukopenia  1  10/139 (7.19%)  9/139 (6.47%) 
Neutropenia  1  63/139 (45.32%)  66/139 (47.48%) 
Thrombocytopenia  1  34/139 (24.46%)  17/139 (12.23%) 
Eye disorders     
Conjunctivitis  1  16/139 (11.51%)  4/139 (2.88%) 
Lacrimation increased  1  7/139 (5.04%)  6/139 (4.32%) 
Vision blurred  1  8/139 (5.76%)  3/139 (2.16%) 
Gastrointestinal disorders     
Abdominal pain  1  25/139 (17.99%)  25/139 (17.99%) 
Abdominal pain upper  1  11/139 (7.91%)  12/139 (8.63%) 
Cheilitis  1  8/139 (5.76%)  0/139 (0.00%) 
Constipation  1  44/139 (31.65%)  44/139 (31.65%) 
Diarrhoea  1  84/139 (60.43%)  84/139 (60.43%) 
Dyspepsia  1  14/139 (10.07%)  15/139 (10.79%) 
Flatulence  1  10/139 (7.19%)  6/139 (4.32%) 
Haemorrhoids  1  4/139 (2.88%)  7/139 (5.04%) 
Nausea  1  75/139 (53.96%)  83/139 (59.71%) 
Rectal haemorrhage  1  7/139 (5.04%)  6/139 (4.32%) 
Stomatitis  1  46/139 (33.09%)  31/139 (22.30%) 
Vomiting  1  43/139 (30.94%)  38/139 (27.34%) 
General disorders     
Asthenia  1  50/139 (35.97%)  44/139 (31.65%) 
Chills  1  11/139 (7.91%)  12/139 (8.63%) 
Fatigue  1  50/139 (35.97%)  65/139 (46.76%) 
Mucosal inflammation  1  49/139 (35.25%)  21/139 (15.11%) 
Oedema peripheral  1  18/139 (12.95%)  13/139 (9.35%) 
Pyrexia  1  21/139 (15.11%)  30/139 (21.58%) 
Temperature intolerance  1  7/139 (5.04%)  11/139 (7.91%) 
Infections and infestations     
Bronchitis  1  4/139 (2.88%)  8/139 (5.76%) 
Nasopharyngitis  1  7/139 (5.04%)  8/139 (5.76%) 
Paronychia  1  25/139 (17.99%)  2/139 (1.44%) 
Respiratory tract infection  1  7/139 (5.04%)  5/139 (3.60%) 
Rhinitis  1  9/139 (6.47%)  5/139 (3.60%) 
Upper respiratory tract infection  1  4/139 (2.88%)  9/139 (6.47%) 
Urinary tract infection  1  9/139 (6.47%)  10/139 (7.19%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  9/139 (6.47%)  6/139 (4.32%) 
Investigations     
Platelet count decreased  1  10/139 (7.19%)  5/139 (3.60%) 
Weight decreased  1  31/139 (22.30%)  16/139 (11.51%) 
Weight increased  1  8/139 (5.76%)  2/139 (1.44%) 
Metabolism and nutrition disorders     
Decreased appetite  1  56/139 (40.29%)  44/139 (31.65%) 
Dehydration  1  18/139 (12.95%)  10/139 (7.19%) 
Hypoalbuminaemia  1  3/139 (2.16%)  7/139 (5.04%) 
Hypocalcaemia  1  12/139 (8.63%)  5/139 (3.60%) 
Hypokalaemia  1  38/139 (27.34%)  18/139 (12.95%) 
Hypomagnesaemia  1  57/139 (41.01%)  9/139 (6.47%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/139 (5.76%)  14/139 (10.07%) 
Back pain  1  12/139 (8.63%)  14/139 (10.07%) 
Muscular weakness  1  3/139 (2.16%)  7/139 (5.04%) 
Musculoskeletal chest pain  1  3/139 (2.16%)  7/139 (5.04%) 
Musculoskeletal pain  1  7/139 (5.04%)  9/139 (6.47%) 
Neck pain  1  2/139 (1.44%)  7/139 (5.04%) 
Pain in extremity  1  12/139 (8.63%)  18/139 (12.95%) 
Nervous system disorders     
Dizziness  1  16/139 (11.51%)  15/139 (10.79%) 
Dysaesthesia  1  13/139 (9.35%)  23/139 (16.55%) 
Dysgeusia  1  31/139 (22.30%)  27/139 (19.42%) 
Headache  1  12/139 (8.63%)  15/139 (10.79%) 
Neuropathy peripheral  1  44/139 (31.65%)  45/139 (32.37%) 
Neurotoxicity  1  15/139 (10.79%)  13/139 (9.35%) 
Paraesthesia  1  25/139 (17.99%)  31/139 (22.30%) 
Peripheral sensory neuropathy  1  24/139 (17.27%)  24/139 (17.27%) 
Polyneuropathy  1  18/139 (12.95%)  16/139 (11.51%) 
Psychiatric disorders     
Anxiety  1  10/139 (7.19%)  8/139 (5.76%) 
Insomnia  1  14/139 (10.07%)  19/139 (13.67%) 
Renal and urinary disorders     
Proteinuria  1  15/139 (10.79%)  11/139 (7.91%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/139 (12.23%)  13/139 (9.35%) 
Dysphonia  1  4/139 (2.88%)  8/139 (5.76%) 
Dyspnoea  1  15/139 (10.79%)  18/139 (12.95%) 
Epistaxis  1  29/139 (20.86%)  32/139 (23.02%) 
Oropharyngeal pain  1  4/139 (2.88%)  12/139 (8.63%) 
Pulmonary embolism  1  7/139 (5.04%)  8/139 (5.76%) 
Rhinorrhoea  1  3/139 (2.16%)  13/139 (9.35%) 
Skin and subcutaneous tissue disorders     
Acne  1  35/139 (25.18%)  1/139 (0.72%) 
Alopecia  1  25/139 (17.99%)  21/139 (15.11%) 
Dermatitis acneiform  1  27/139 (19.42%)  1/139 (0.72%) 
Dry skin  1  53/139 (38.13%)  12/139 (8.63%) 
Erythema  1  11/139 (7.91%)  2/139 (1.44%) 
Exfoliative rash  1  11/139 (7.91%)  2/139 (1.44%) 
Hypertrichosis  1  9/139 (6.47%)  0/139 (0.00%) 
Nail disorder  1  12/139 (8.63%)  6/139 (4.32%) 
Palmar-plantar erythrodysaesthesia syndrome  1  22/139 (15.83%)  14/139 (10.07%) 
Pruritus  1  16/139 (11.51%)  4/139 (2.88%) 
Rash  1  86/139 (61.87%)  9/139 (6.47%) 
Skin fissures  1  29/139 (20.86%)  1/139 (0.72%) 
Skin toxicity  1  8/139 (5.76%)  0/139 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  5/139 (3.60%)  10/139 (7.19%) 
Haematoma  1  1/139 (0.72%)  7/139 (5.04%) 
Hypertension  1  6/139 (4.32%)  35/139 (25.18%) 
Hypotension  1  7/139 (5.04%)  6/139 (4.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00819780     History of Changes
Other Study ID Numbers: 20070509
First Submitted: November 6, 2008
First Posted: January 9, 2009
Results First Submitted: July 10, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 29, 2018