Trial Outcomes & Findings for Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer (NCT NCT00089635)

NCT ID: NCT00089635

Last Updated: 2022-11-07

Results Overview

Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 203 participants
• Primary outcome timeframe: From enrollment through Week 16
• Results posted on: 2022-11-07

Participant Flow

Participants were enrolled from 11 August 2004 through 2 August 2006

Participant milestones

Measure	Panitumumab Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Study STARTED	203
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Measure	Panitumumab Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Study Adverse Event	2
Overall Study Death	17
Overall Study Disease Progression	12
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	6
Overall Study Ineligibility determined	1
Overall Study Other	2

Baseline Characteristics

Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Measure	Panitumumab n=203 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	34 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	13 participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	151 participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment through Week 16

Population: Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.

Outcome measures

Measure	Panitumumab n=158 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Objective Tumor Response Through Week 16	6 participants

PRIMARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.

Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.

Outcome measures

Measure	Panitumumab n=7 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Duration of Response	22.2 weeks Interval 16.1 to 28.4

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.

Outcome measures

Measure	Panitumumab n=158 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Objective Tumor Response Throughout the Study	7 participants

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.

Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.

Outcome measures

Measure	Panitumumab n=7 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Time to Initial Objective Response	11 weeks Interval 7.0 to 23.0

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.

Outcome measures

Measure	Panitumumab n=158 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Progression-free Survival Time	8.1 weeks Interval 7.4 to 11.3

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.

Outcome measures

Measure	Panitumumab n=158 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Time to Disease Progression	8.3 weeks Interval 7.4 to 11.3

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.

Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.

Outcome measures

Measure	Panitumumab n=158 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Time to Treatment Failure	8.4 weeks Interval 8.1 to 11.3

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.

Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.

Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started.

Outcome measures

Measure	Panitumumab n=52 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Duration of Stable Disease	16.0 weeks Interval 15.3 to 22.9

SECONDARY outcome

Timeframe: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.

Population: Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).

Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.

Outcome measures

Measure	Panitumumab n=158 Participants Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Overall Survival	9.0 months Interval 8.1 to 11.2

Adverse Events

Panitumumab

Serious events: 61 serious events

Other events: 200 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panitumumab n=203 participants at risk Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Blood and lymphatic system disorders Anaemia	1.5% 3/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Lymphadenopathy	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute myocardial infarction	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina unstable	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal discomfort	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	3.0% 6/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	1.5% 3/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ascites	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haematochezia	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	2.0% 4/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small intestinal obstruction	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Infusion related reaction	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	2.0% 4/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Bile duct obstruction	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hyperbilirubinaemia	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Anaphylactic reaction	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Hypersensitivity	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Klebsiella bacteraemia	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pyelonephritis	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Compression fracture	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Exposure to toxic agent	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Incisional hernia	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Pelvic fracture	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Prothrombin time prolonged	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Urine output decreased	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	3.0% 6/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Failure to thrive	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperkalaemia	1.5% 3/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypocalcaemia	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypokalaemia	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	2.0% 4/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. 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) Brain neoplasm	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. 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	3.0% 6/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. 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	2.5% 5/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. 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	3.0% 6/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. 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 metastatic	2.0% 4/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular accident	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Convulsion	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Depressed level of consciousness	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Spinal cord compression	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Tremor	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Confusional state	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Hallucination	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.99% 2/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.0% 6/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 3/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.49% 1/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Panitumumab n=203 participants at risk Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Blood and lymphatic system disorders ANAEMIA	6.9% 14/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders CONJUNCTIVITIS	5.4% 11/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders ABDOMINAL DISTENSION	6.4% 13/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders ABDOMINAL PAIN	15.3% 31/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	6.9% 14/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders CONSTIPATION	16.7% 34/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders DIARRHOEA	27.1% 55/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders NAUSEA	33.5% 68/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders STOMATITIS	7.4% 15/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders VOMITING	26.1% 53/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders ASTHENIA	9.4% 19/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders FATIGUE	35.0% 71/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders OEDEMA PERIPHERAL	12.8% 26/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders PYREXIA	9.4% 19/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations PARONYCHIA	20.7% 42/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations RASH PUSTULAR	8.9% 18/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.4% 11/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations WEIGHT DECREASED	11.8% 24/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders ANOREXIA	21.7% 44/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders DEHYDRATION	6.4% 13/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders HYPOCALCAEMIA	5.4% 11/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders HYPOKALAEMIA	6.9% 14/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	13.8% 28/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.4% 15/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders BACK PAIN	10.3% 21/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders DIZZINESS	6.9% 14/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders HEADACHE	8.9% 18/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders NEUROPATHY PERIPHERAL	5.4% 11/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders ANXIETY	6.9% 14/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders DEPRESSION	5.4% 11/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders INSOMNIA	9.4% 19/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders COUGH	13.8% 28/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	16.3% 33/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders ACNE	5.4% 11/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	69.5% 141/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders DRY SKIN	20.2% 41/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders ERYTHEMA	67.5% 137/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders EXFOLIATIVE RASH	23.6% 48/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders NAIL DISORDER	5.9% 12/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders PRURITUS	69.0% 140/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders RASH	29.1% 59/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders RASH PAPULAR	6.9% 14/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	11.3% 23/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders SKIN FISSURES	15.3% 31/203 • First dose date through the safety follow-up visit. The median time frame is 2.6 months. 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER