Trial Outcomes & Findings for Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy (NCT NCT00083616)
NCT ID: NCT00083616
Last Updated: 2014-01-10
Results Overview
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
16 weeks
Results posted on
2014-01-10
Participant Flow
Participants were enrolled from 1 March 2004 through 19 Jul 2006. Patient disposition is reported up until the data cut-off date of 22 December 2006. Completed study is defined as participants who either died on study or completed the safety follow-up visit (30 days after the last dose of panitumumab).
Participant milestones
| Measure |
Panitumumab (ABX-EGF)
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Overall Study
STARTED
|
185
|
|
Overall Study
Received Study Medication
|
182
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Panitumumab (ABX-EGF)
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Overall Study
Disease Progression
|
16
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Ineligibility determined
|
2
|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Baseline characteristics by cohort
| Measure |
Panitumumab
n=185 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 10.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
144 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Outcome measures
| Measure |
Panitumumab
n=142 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Number of Participants With Objective Tumor Response Through Week 16
|
5 Participants
|
PRIMARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.Population: Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response
The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Outcome measures
| Measure |
Panitumumab
n=5 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Duration of Response
|
14.0 Weeks
Interval 12.4 to 101.7
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.Population: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Outcome measures
| Measure |
Panitumumab
n=142 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Number of Participants With Objective Tumor Response Throughout Study
|
5 Participants
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.Population: Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response
Median time from enrollment to objective tumor response for participants who responded.
Outcome measures
| Measure |
Panitumumab
n=5 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Time to Response
|
11.0 Weeks
Interval 7.7 to 11.1
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.Population: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.
Outcome measures
| Measure |
Panitumumab
n=142 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Progression-free Survival Time
|
7.3 Weeks
Interval 7.1 to 7.4
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.Population: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.
Outcome measures
| Measure |
Panitumumab
n=142 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Time to Disease Progression
|
7.3 Weeks
Interval 7.1 to 7.6
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.Population: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.
Outcome measures
| Measure |
Panitumumab
n=142 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Time to Treatment Failure
|
8.0 Weeks
Interval 7.4 to 8.1
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.Population: Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease
Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.
Outcome measures
| Measure |
Panitumumab
n=31 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Duration of Stable Disease
|
23.9 Weeks
Interval 23.0 to 31.0
|
SECONDARY outcome
Timeframe: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.Population: Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)
Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up.
Outcome measures
| Measure |
Panitumumab
n=142 Participants
Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
|
|---|---|
|
Overall Survival
|
7.0 months
Interval 5.7 to 8.0
|
Adverse Events
Panitumumab
Serious events: 62 serious events
Other events: 176 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panitumumab
n=182 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
3/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
4/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
3/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
6/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Early satiety
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pain
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholangitis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Catheter related infection
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Folliculitis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lobar pneumonia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
1.6%
3/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia bacterial
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pyelonephritis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Septic embolus
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Septic shock
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urosepsis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
3.3%
6/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
3.3%
6/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
2.7%
5/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Speech disorder
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Spinal cord compression
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
7/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
2/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
3/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
4/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Circulatory collapse
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
3/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
0.55%
1/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Panitumumab
n=182 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
18.7%
34/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Ascites
|
6.0%
11/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
19.8%
36/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.4%
48/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
12/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
31.9%
58/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
16/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
20.9%
38/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
6.6%
12/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chills
|
6.0%
11/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
36.3%
66/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
9.3%
17/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
12.6%
23/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Paronychia
|
17.6%
32/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Rash pustular
|
8.8%
16/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
13/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
10.4%
19/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.0%
31/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
11/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.6%
12/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.2%
15/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.0%
20/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
21/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
10/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
6.6%
12/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
9.9%
18/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
7.7%
14/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
5.5%
10/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
8.8%
16/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.2%
24/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
29/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.5%
10/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
68.7%
125/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
28/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
61.5%
112/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
16.5%
30/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
8.2%
15/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
52.7%
96/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.2%
44/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.6%
12/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
9.3%
17/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
13.2%
24/182 • From the first dose through maximum of safety follow-up or 30 days after last dose; maximum time on study treatment was 1.25 years.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER