Trial Outcomes & Findings for Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (NCT NCT00460265)

NCT ID: NCT00460265

Last Updated: 2014-03-07

Results Overview

Time from randomization to death

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

658 participants

Primary outcome timeframe

Upto 56 months

Results posted on

2014-03-07

Participant Flow

Subjects were enrolled from 25 May 2007 to 10 March 2009.

Participant milestones

Participant milestones
Measure	Panitumumab Plus Chemotherapy Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone Consists of Cisplatin and 5-FU
Overall Study STARTED	328	330
Overall Study Randomized While Alive	327	330
Overall Study Received Study Medication	325	325
Overall Study COMPLETED	243	241
Overall Study NOT COMPLETED	85	89

Reasons for withdrawal

Reasons for withdrawal
Measure	Panitumumab Plus Chemotherapy Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone Consists of Cisplatin and 5-FU
Overall Study Lost to Follow-up	14	15
Overall Study Physician Decision	1	2
Overall Study Withdrawal by Subject	10	25
Overall Study Ongoing	60	47

Baseline Characteristics

Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panitumumab Plus Chemotherapy n=327 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=330 Participants Consists of Cisplatin and 5-FU	Total n=657 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 8.5 • n=99 Participants	58.6 years STANDARD_DEVIATION 7.8 • n=107 Participants	58.1 years STANDARD_DEVIATION 8.2 • n=206 Participants
Sex: Female, Male Female	44 Participants n=99 Participants	43 Participants n=107 Participants	87 Participants n=206 Participants
Sex: Female, Male Male	283 Participants n=99 Participants	287 Participants n=107 Participants	570 Participants n=206 Participants
Race/Ethnicity, Customized White or Caucasian	268 subjects n=99 Participants	271 subjects n=107 Participants	539 subjects n=206 Participants
Race/Ethnicity, Customized Black or African American	4 subjects n=99 Participants	2 subjects n=107 Participants	6 subjects n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	13 subjects n=99 Participants	12 subjects n=107 Participants	25 subjects n=206 Participants
Race/Ethnicity, Customized Asian	25 subjects n=99 Participants	30 subjects n=107 Participants	55 subjects n=206 Participants
Race/Ethnicity, Customized Japanese	13 subjects n=99 Participants	7 subjects n=107 Participants	20 subjects n=206 Participants
Race/Ethnicity, Customized Aborigine	1 subjects n=99 Participants	0 subjects n=107 Participants	1 subjects n=206 Participants
Race/Ethnicity, Customized Other	3 subjects n=99 Participants	6 subjects n=107 Participants	9 subjects n=206 Participants
Race/Ethnicity, Customized Unknown/Missing	0 subjects n=99 Participants	2 subjects n=107 Participants	2 subjects n=206 Participants
Previously treated with chemotherapy and/or radiotherapy, Yes/No Yes	267 subjects n=99 Participants	263 subjects n=107 Participants	530 subjects n=206 Participants
Previously treated with chemotherapy and/or radiotherapy, Yes/No No	60 subjects n=99 Participants	67 subjects n=107 Participants	127 subjects n=206 Participants
ECOG perfomance score, 0/1/2 0	98 subjects n=99 Participants	98 subjects n=107 Participants	196 subjects n=206 Participants
ECOG perfomance score, 0/1/2 1	227 subjects n=99 Participants	228 subjects n=107 Participants	455 subjects n=206 Participants
ECOG perfomance score, 0/1/2 2	2 subjects n=99 Participants	4 subjects n=107 Participants	6 subjects n=206 Participants
Primary tumor site, oropharynx&larynx/oral cavity&hypopharynx Oropharynx and larynx	186 subjects n=99 Participants	191 subjects n=107 Participants	377 subjects n=206 Participants
Primary tumor site, oropharynx&larynx/oral cavity&hypopharynx Oral cavity and hypopharynx	141 subjects n=99 Participants	139 subjects n=107 Participants	280 subjects n=206 Participants

PRIMARY outcome

Timeframe: Upto 56 months

Population: Intention to treat (ITT)

Time from randomization to death

Outcome measures

Outcome measures
Measure	Panitumumab Plus Chemotherapy n=327 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=330 Participants Consists of Cisplatin and 5-FU
Overall Survival	11.1 months Interval 9.8 to 12.2	9.0 months Interval 8.1 to 11.2

SECONDARY outcome

Timeframe: Every 6 weeks until disease progression, up to 56 months

Population: The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H)

An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.

Outcome measures

Outcome measures
Measure	Panitumumab Plus Chemotherapy n=278 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=288 Participants Consists of Cisplatin and 5-FU
Overall Response Rate	101 subjects	73 subjects

SECONDARY outcome

Timeframe: Every 6 weeks until disease progression, up to 56 months

Population: Included only those subjects with a confirmed complete or partial response.

Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).

Outcome measures

Outcome measures
Measure	Panitumumab Plus Chemotherapy n=101 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=73 Participants Consists of Cisplatin and 5-FU
Duration of Response	5.6 months Interval 4.8 to 6.2	5.7 months Interval 4.7 to 6.2

SECONDARY outcome

Timeframe: Every 6 weeks until disease progression, up to 56 months

Population: ITT

Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)

Outcome measures

Outcome measures
Measure	Panitumumab Plus Chemotherapy n=327 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=330 Participants Consists of Cisplatin and 5-FU
Time to Progression	6.8 months Interval 5.9 to 6.9	5.6 months Interval 5.2 to 5.8

SECONDARY outcome

Timeframe: Every 6 weeks until disease progression, upto 56 months

Population: Included only those subjects with a confirmed complete response or partial response.

Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.

Outcome measures

Outcome measures
Measure	Panitumumab Plus Chemotherapy n=101 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=73 Participants Consists of Cisplatin and 5-FU
Time to Response	1.4 months Interval 1.3 to 2.5	1.5 months Interval 1.3 to 2.6

SECONDARY outcome

Timeframe: Every 6 weeks until disease progression or deaths, upto 56 months

Population: ITT

Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.

Outcome measures

Outcome measures
Measure	Panitumumab Plus Chemotherapy n=327 Participants Consists of Panitumumab plus Cisplatin and 5-FU	Chemotherapy Alone n=330 Participants Consists of Cisplatin and 5-FU
Progression Free Survival	5.8 months Interval 5.6 to 6.6	4.6 months Interval 4.1 to 5.4

Adverse Events

Panitumumab Plus Chemotherapy

Serious events: 157 serious events

Other events: 311 other events

Deaths: 0 deaths

Chemotherapy Alone

Serious events: 139 serious events

Other events: 301 other events

Deaths: 0 deaths

Serious adverse events

Other 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

Serious adverse events
Measure	Panitumumab Plus Chemotherapy n=325 participants at risk	Chemotherapy Alone n=325 participants at risk
Blood and lymphatic system disorders Anaemia	4.6% 15/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 16/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	5.5% 18/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.7% 12/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Haematotoxicity	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	0.92% 3/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 4/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Lymphadenopathy	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	3.4% 11/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 14/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Pancytopenia	0.92% 3/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	2.5% 8/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 4/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute myocardial infarction	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia supraventricular	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	0.62% 2/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 4/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure	0.92% 3/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure acute	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardio-respiratory arrest	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.5% 5/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiopulmonary failure	0.62% 2/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Intracardiac thrombus	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sinus arrhythmia	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Ichthyosis	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Hypoacusis	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Vertigo	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.62% 2/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Papilloedema	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinal artery occlusion	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vision blurred	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Aphagia	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ascites	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	2.8% 9/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 4/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Duodenal ulcer	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	0.92% 3/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 7/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Faecaloma	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events
Measure	Panitumumab Plus Chemotherapy n=325 participants at risk	Chemotherapy Alone n=325 participants at risk
Blood and lymphatic system disorders Anaemia	40.6% 132/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	38.8% 126/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	15.7% 51/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.1% 49/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	48.3% 157/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	43.1% 140/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	22.8% 74/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.8% 74/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Tinnitus	6.5% 21/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.6% 28/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Conjunctivitis	7.1% 23/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 4/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	6.2% 20/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.1% 10/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	6.8% 22/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.5% 18/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	25.5% 83/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.8% 74/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	37.8% 123/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	23.4% 76/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dyspepsia	7.7% 25/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 20/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	7.1% 23/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.4% 24/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	54.8% 178/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	55.4% 180/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Stomatitis	20.6% 67/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	19.1% 62/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	43.1% 140/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	38.8% 126/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	20.0% 65/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.6% 54/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	27.7% 90/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	24.9% 81/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	21.8% 71/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	19.1% 62/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	6.5% 21/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 22/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	15.4% 50/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.8% 45/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Paronychia	11.1% 36/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.31% 1/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood creatinine increased	7.1% 23/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.2% 33/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight decreased	24.9% 81/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.6% 54/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Decreased appetite	28.9% 94/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.7% 90/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypocalcaemia	12.9% 42/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 20/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypokalaemia	14.5% 47/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.2% 43/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	40.6% 132/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.3% 66/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	8.0% 26/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 16/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck pain	4.6% 15/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 20/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	8.6% 28/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 21/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	8.9% 29/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.8% 35/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neuropathy peripheral	8.3% 27/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.2% 20/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	8.3% 27/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 21/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	12.6% 41/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.2% 30/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.5% 31/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.8% 19/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.4% 11/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.8% 19/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Acne	8.3% 27/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.92% 3/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Alopecia	15.1% 49/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.1% 36/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	14.8% 48/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dry skin	13.8% 45/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.2% 4/325 • The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months) The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.