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Trial record 3 of 19 for:    colon cancer | ( Map: Mexico )

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01412957
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : April 8, 2016
Last Update Posted : March 15, 2017
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 Other: Best Supportive Care (BSC)
Drug: Panitumumab
Enrollment 377
Recruitment Details

A total of 377 participants were randomized at 66 centers in Europe, Asia, North and South America from 8 November 2011 until 30 July 2013.

Results are reported as of the primary analysis data cut-off date of 10 June 2014.

Pre-assignment Details Participants were stratified according to geographic region (Europe vs Asia vs rest of the world) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2) and randomized (1:1 ratio) to 1 of 2 treatment groups.
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug. Participants received best supportive care until disease progression, withdrawal of consent, or death.
Period Title: Overall Study
Started 189 188
Completed 40 [1] 31 [1]
Not Completed 149 157
Reason Not Completed
Withdrawal by Subject             6             22
Lost to Follow-up             7             2
Death             136             133
[1]
Participants continuing study at the time of data cut-off
Arm/Group Title Panitumumab + BSC BSC Alone Total
Hide Arm/Group Description Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug. Participants received best supportive care until disease progression, withdrawal of consent, or death. Total of all reporting groups
Overall Number of Baseline Participants 189 188 377
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants 188 participants 377 participants
60.2  (10.7) 58.7  (11.1) 59.4  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Female
82
  43.4%
79
  42.0%
161
  42.7%
Male
107
  56.6%
109
  58.0%
216
  57.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Hispanic or Latino 23 22 45
Not Hispanic or Latino 166 166 332
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
American Indian or Alaska Native 0 3 3
Asian 79 82 161
White 107 102 209
Other 3 1 4
Geographic Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Europe 86 85 171
Asia 80 82 162
Rest of world 23 21 44
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Grade 0 71 65 136
Grade 1 100 107 207
Grade 2 18 16 34
[1]
Measure Description: A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
Location of Primary Tumor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Colon 108 106 214
Rectum 81 81 162
Missing 0 1 1
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
Time Frame From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 189 188
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(8.7 to 11.4)
7.4
(5.8 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab + BSC, BSC Alone
Comments The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments [Not Specified]
Method Log Rank
Comments Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Method of Estimation Estimation Parameter Normal score
Estimated Value -2.59
Estimation Comments A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Time Frame From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 189 188
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(3.4 to 5.3)
1.7
(1.6 to 1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab + BSC, BSC Alone
Comments PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Method of Estimation Estimation Parameter Normal score
Estimated Value -6.08
Estimation Comments A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
3.Secondary Outcome
Title Overall Survival in Participants With Wild-type RAS
Hide Description A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
Time Frame From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 142 128
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(8.7 to 11.6)
6.9
(5.2 to 7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab + BSC, BSC Alone
Comments Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments [Not Specified]
Method Log Rank
Comments Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Method of Estimation Estimation Parameter Normal score
Estimated Value -2.47
Estimation Comments A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
4.Secondary Outcome
Title Progression Free Survival (PFS) in Participants With Wild-type RAS
Hide Description

PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death.

Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.

Time Frame From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS Efficacy Analysis Set
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 142 128
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(3.5 to 5.3)
1.7
(1.6 to 2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab + BSC, BSC Alone
Comments PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Method of Estimation Estimation Parameter Normal score
Estimated Value -5.98
Estimation Comments A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.
5.Secondary Outcome
Title Objective Response Rate
Hide Description Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with 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 lesions not qualifying for either CR or PD and no new lesions.
Time Frame Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 189 188
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.98
(20.80 to 33.91)
1.60
(0.33 to 4.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab + BSC, BSC Alone
Comments ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified exact test
Comments Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 24.89
Confidence Interval (2-Sided) 95%
7.47 to 123.77
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.
6.Secondary Outcome
Title Objective Response Rate in Participants With Wild-type RAS
Hide Description Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with 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 lesions not qualifying for either CR or PD and no new lesions.
Time Frame Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Wild-type RAS Efficacy Analysis Set
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 142 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.99
(23.50 to 39.28)
2.34
(0.49 to 6.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab + BSC, BSC Alone
Comments ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified exact test
Comments Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 20.00
Confidence Interval (2-Sided) 95%
5.89 to 101.62
Estimation Comments The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.
Time Frame From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
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Safety Analysis Set (all randomized participants)
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 189 188
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 184 115
AE with worst grade of 3 70 29
AE with worst grade of 4 17 5
AE with worst grade of 5 8 15
Serious adverse event (SAE) 48 37
AE leading to discontinuation of panitumumab 20 NA [1] 
Treatment-related adverse event (TRAE) 166 7
Treatment-related AE with worst grade of 3 41 1
Treatment-related AE with worst grade of 4 4 1
Treatment-related AE with worst grade of 5 0 1
Serious treatment-related AE 2 3
TRAE leading to discontinuation of panitumumab 1 NA [1] 
[1]
Not applicable for BSC Alone arm
8.Secondary Outcome
Title Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval
Hide Description QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).
Time Frame Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)
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Hide Analysis Population Description
QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.
Arm/Group Title Panitumumab + BSC BSC Alone
Hide Arm/Group Description:
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Overall Number of Participants Analyzed 53 0
Mean (Standard Deviation)
Unit of Measure: msec
QTcF 14.58  (13.60)
QTcB 12.57  (12.15)
Time Frame From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Panitumumab Plus BSC BSC Alone
Hide Arm/Group Description [Not Specified] Participants received best supportive care until disease progression, withdrawal of consent, or death.
All-Cause Mortality
Panitumumab Plus BSC BSC Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panitumumab Plus BSC BSC Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   48/189 (25.40%)   37/188 (19.68%) 
Blood and lymphatic system disorders     
Anaemia  1  1/189 (0.53%)  2/188 (1.06%) 
Bone marrow toxicity  1  0/189 (0.00%)  1/188 (0.53%) 
Cardiac disorders     
Acute myocardial infarction  1  1/189 (0.53%)  0/188 (0.00%) 
Angina unstable  1  1/189 (0.53%)  0/188 (0.00%) 
Cardiac failure congestive  1  0/189 (0.00%)  1/188 (0.53%) 
Myocardial ischaemia  1  1/189 (0.53%)  0/188 (0.00%) 
Pericardial effusion  1  1/189 (0.53%)  0/188 (0.00%) 
Congenital, familial and genetic disorders     
Pyloric stenosis  1  1/189 (0.53%)  0/188 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/189 (0.00%)  1/188 (0.53%) 
Eye disorders     
Diplopia  1  0/189 (0.00%)  1/188 (0.53%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/189 (0.53%)  0/188 (0.00%) 
Abdominal pain  1  3/189 (1.59%)  3/188 (1.60%) 
Anal fistula  1  1/189 (0.53%)  0/188 (0.00%) 
Diarrhoea  1  0/189 (0.00%)  1/188 (0.53%) 
Gastric ulcer haemorrhage  1  1/189 (0.53%)  0/188 (0.00%) 
Gastrointestinal necrosis  1  1/189 (0.53%)  0/188 (0.00%) 
Gastrointestinal obstruction  1  0/189 (0.00%)  1/188 (0.53%) 
Ileus  1  3/189 (1.59%)  1/188 (0.53%) 
Intestinal obstruction  1  3/189 (1.59%)  3/188 (1.60%) 
Large intestinal obstruction  1  0/189 (0.00%)  1/188 (0.53%) 
Lower gastrointestinal haemorrhage  1  0/189 (0.00%)  1/188 (0.53%) 
Nausea  1  1/189 (0.53%)  0/188 (0.00%) 
Proctalgia  1  0/189 (0.00%)  1/188 (0.53%) 
Rectal haemorrhage  1  1/189 (0.53%)  0/188 (0.00%) 
Subileus  1  1/189 (0.53%)  0/188 (0.00%) 
Vomiting  1  0/189 (0.00%)  1/188 (0.53%) 
General disorders     
Asthenia  1  1/189 (0.53%)  0/188 (0.00%) 
Chills  1  1/189 (0.53%)  0/188 (0.00%) 
Fatigue  1  1/189 (0.53%)  2/188 (1.06%) 
General physical health deterioration  1  0/189 (0.00%)  3/188 (1.60%) 
Malaise  1  1/189 (0.53%)  0/188 (0.00%) 
Oedema peripheral  1  1/189 (0.53%)  0/188 (0.00%) 
Pain  1  1/189 (0.53%)  0/188 (0.00%) 
Pyrexia  1  0/189 (0.00%)  2/188 (1.06%) 
Hepatobiliary disorders     
Bile duct stenosis  1  0/189 (0.00%)  1/188 (0.53%) 
Hepatic failure  1  1/189 (0.53%)  0/188 (0.00%) 
Hepatic function abnormal  1  1/189 (0.53%)  1/188 (0.53%) 
Hyperbilirubinaemia  1  1/189 (0.53%)  1/188 (0.53%) 
Jaundice cholestatic  1  1/189 (0.53%)  0/188 (0.00%) 
Infections and infestations     
Abscess  1  0/189 (0.00%)  1/188 (0.53%) 
Anal abscess  1  2/189 (1.06%)  0/188 (0.00%) 
Bronchitis  1  1/189 (0.53%)  0/188 (0.00%) 
Device related infection  1  1/189 (0.53%)  0/188 (0.00%) 
Lung abscess  1  0/189 (0.00%)  1/188 (0.53%) 
Pneumonia  1  1/189 (0.53%)  0/188 (0.00%) 
Sepsis  1  0/189 (0.00%)  1/188 (0.53%) 
Urinary tract infection  1  1/189 (0.53%)  0/188 (0.00%) 
Injury, poisoning and procedural complications     
Humerus fracture  1  0/189 (0.00%)  1/188 (0.53%) 
Investigations     
Blood bilirubin increased  1  1/189 (0.53%)  0/188 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/189 (0.53%)  0/188 (0.00%) 
Musculoskeletal and connective tissue disorders     
Spinal pain  1  0/189 (0.00%)  1/188 (0.53%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  3/189 (1.59%)  3/188 (1.60%) 
Colorectal cancer  1  1/189 (0.53%)  3/188 (1.60%) 
Colorectal cancer metastatic  1  2/189 (1.06%)  1/188 (0.53%) 
Colorectal cancer recurrent  1  1/189 (0.53%)  0/188 (0.00%) 
Malignant neoplasm progression  1  0/189 (0.00%)  1/188 (0.53%) 
Metastases to central nervous system  1  2/189 (1.06%)  1/188 (0.53%) 
Metastases to ovary  1  1/189 (0.53%)  0/188 (0.00%) 
Rectal cancer  1  0/189 (0.00%)  1/188 (0.53%) 
Nervous system disorders     
Brain oedema  1  0/189 (0.00%)  1/188 (0.53%) 
Cerebral infarction  1  1/189 (0.53%)  0/188 (0.00%) 
Cerebrovascular accident  1  0/189 (0.00%)  1/188 (0.53%) 
Convulsion  1  2/189 (1.06%)  0/188 (0.00%) 
Dizziness  1  0/189 (0.00%)  1/188 (0.53%) 
Headache  1  0/189 (0.00%)  2/188 (1.06%) 
Peripheral sensory neuropathy  1  0/189 (0.00%)  1/188 (0.53%) 
Speech disorder  1  0/189 (0.00%)  1/188 (0.53%) 
Spinal cord compression  1  1/189 (0.53%)  1/188 (0.53%) 
Wallenberg syndrome  1  1/189 (0.53%)  0/188 (0.00%) 
Renal and urinary disorders     
Hydronephrosis  1  1/189 (0.53%)  1/188 (0.53%) 
Obstructive uropathy  1  1/189 (0.53%)  0/188 (0.00%) 
Ureteric obstruction  1  0/189 (0.00%)  1/188 (0.53%) 
Urinary tract inflammation  1  1/189 (0.53%)  0/188 (0.00%) 
Reproductive system and breast disorders     
Pelvic pain  1  1/189 (0.53%)  0/188 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/189 (0.53%)  0/188 (0.00%) 
Asthma  1  1/189 (0.53%)  0/188 (0.00%) 
Pneumothorax  1  0/189 (0.00%)  1/188 (0.53%) 
Respiratory distress  1  0/189 (0.00%)  1/188 (0.53%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/189 (0.53%)  0/188 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab Plus BSC BSC Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   174/189 (92.06%)   74/188 (39.36%) 
Blood and lymphatic system disorders     
Anaemia  1  15/189 (7.94%)  16/188 (8.51%) 
Gastrointestinal disorders     
Abdominal pain  1  28/189 (14.81%)  18/188 (9.57%) 
Constipation  1  15/189 (7.94%)  12/188 (6.38%) 
Diarrhoea  1  25/189 (13.23%)  7/188 (3.72%) 
Dyspepsia  1  10/189 (5.29%)  2/188 (1.06%) 
Nausea  1  11/189 (5.82%)  10/188 (5.32%) 
Stomatitis  1  12/189 (6.35%)  0/188 (0.00%) 
Vomiting  1  12/189 (6.35%)  7/188 (3.72%) 
General disorders     
Fatigue  1  28/189 (14.81%)  14/188 (7.45%) 
Pyrexia  1  16/189 (8.47%)  9/188 (4.79%) 
Infections and infestations     
Conjunctivitis  1  12/189 (6.35%)  0/188 (0.00%) 
Paronychia  1  27/189 (14.29%)  0/188 (0.00%) 
Investigations     
Weight decreased  1  13/189 (6.88%)  4/188 (2.13%) 
Metabolism and nutrition disorders     
Decreased appetite  1  18/189 (9.52%)  16/188 (8.51%) 
Hypocalcaemia  1  13/189 (6.88%)  1/188 (0.53%) 
Hypokalaemia  1  10/189 (5.29%)  1/188 (0.53%) 
Hypomagnesaemia  1  53/189 (28.04%)  2/188 (1.06%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  12/189 (6.35%)  10/188 (5.32%) 
Skin and subcutaneous tissue disorders     
Acne  1  26/189 (13.76%)  0/188 (0.00%) 
Dermatitis acneiform  1  54/189 (28.57%)  0/188 (0.00%) 
Dry skin  1  29/189 (15.34%)  1/188 (0.53%) 
Erythema  1  23/189 (12.17%)  0/188 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  19/189 (10.05%)  0/188 (0.00%) 
Pruritus  1  47/189 (24.87%)  0/188 (0.00%) 
Rash  1  73/189 (38.62%)  2/188 (1.06%) 
Rash maculo-papular  1  10/189 (5.29%)  0/188 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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 after completion. 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
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01412957     History of Changes
Other Study ID Numbers: 20100007
2010-022951-49 ( EudraCT Number )
First Submitted: March 31, 2011
First Posted: August 9, 2011
Results First Submitted: March 2, 2016
Results First Posted: April 8, 2016
Last Update Posted: March 15, 2017