Trial Outcomes & Findings for Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance) (NCT NCT02089737)

NCT ID: NCT02089737

Last Updated: 2017-04-06

Results Overview

The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

• Recruitment status: COMPLETED
• Target enrollment: 3091 participants
• Primary outcome timeframe: Baseline through Week 42
• Results posted on: 2017-04-06

Participant Flow

Participants enrolled during the period from June 1, 2010 to November 14, 2010 were surveyed.

Surveyed participants had a clinical diagnosis of wild-type KRAS unresectable advanced/recurrent colorectal cancer.

Participant milestones

Measure	Panitumumab Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
Overall Study STARTED	3091
Overall Study COMPLETED	3085
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Panitumumab Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
Overall Study Survey form not completed	5
Overall Study Not treated	1

Baseline Characteristics

Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

Baseline characteristics by cohort

Measure	Panitumumab n=3085 Participants Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
Age, Customized < 75 years	2582 Participants n=93 Participants
Age, Customized >= 75 years	503 Participants n=93 Participants
Sex: Female, Male Female	1120 Participants n=93 Participants
Sex: Female, Male Male	1965 Participants n=93 Participants
Race/Ethnicity, Customized Asian	3085 Participants n=93 Participants
Region of Enrollment Japan	3085 Participants n=93 Participants
KRAS genotype Wild type	3003 Participants n=93 Participants
KRAS genotype Non-measurable/non-assessable	78 Participants n=93 Participants
KRAS genotype Mutant	3 Participants n=93 Participants
KRAS genotype Not determined	1 Participants n=93 Participants
KRAS genotype Unknown	0 Participants n=93 Participants
Treatment stage (excluding posteroperative adjuvant chemotherapy) First-line	310 Participants n=93 Participants
Treatment stage (excluding posteroperative adjuvant chemotherapy) Second-line	543 Participants n=93 Participants
Treatment stage (excluding posteroperative adjuvant chemotherapy) Third-line or later	2232 Participants n=93 Participants
Treatment stage (excluding posteroperative adjuvant chemotherapy) Unknown	0 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:0	1877 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:1	942 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:2	241 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:3	22 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline PS:4	3 Participants n=93 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline Unknown	0 Participants n=93 Participants
Metastatic lesions/sites of relapse No	38 Participants n=93 Participants
Metastatic lesions/sites of relapse Yes	3046 Participants n=93 Participants
Metastatic lesions/sites of relapse Unknown	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline through Week 42

Population: Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.

The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

Outcome measures

Measure	Panitumumab n=3085 Participants Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
Number of Participants With Adverse Drug Reactions Frequency of adverse drug reactions	2595 Participants
Number of Participants With Adverse Drug Reactions MedDRA SOC: Skin and subcutaneous tissue disorders	2364 Participants
Number of Participants With Adverse Drug Reactions MedDRA SOC: Infections and infestations	771 Participants
Number of Participants With Adverse Drug Reactions MedDRA SOC: Gastrointestinal disorders	642 Participants
Number of Participants With Adverse Drug Reactions MedDRA SOC: Metabolism and nutrition disorders	552 Participants
Number of Participants With Adverse Drug Reactions MedDRA SOC: Cardiac disorders	7 Participants

SECONDARY outcome

Timeframe: Up to Week 42 or death (whichever occurred first)

Population: Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy.

Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.

Outcome measures

Measure	Panitumumab n=1061 Participants Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
Progression-free Survival	3.5 Months Interval 3.3 to 4.0

SECONDARY outcome

Timeframe: Up to Week 42 or death (whichever occurred first)

Population: All participants that received panitumumab monotherapy as a third-line or later therapy.

Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.

Outcome measures

Measure	Panitumumab n=1061 Participants Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
Overall Survival	41 weeks Interval 36.0 to 47.0

Adverse Events

Panitumumab

Serious events: 614 serious events

Other events: 640 other events

Deaths: 0 deaths

Concomitant Administration of Panitumumab and Chemotherapy

Serious events: 747 serious events

Other events: 1084 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panitumumab n=1254 participants at risk Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks	Concomitant Administration of Panitumumab and Chemotherapy n=1831 participants at risk
Infections and infestations Bronchitis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Bronchopneumonia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Cellulitis	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Endocarditis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Fungaemia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Gastroenteritis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Herpes virus infection	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Herpes zoster	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Infection	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Liver Abscess	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Lung abscess	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Necrotizing fasciitis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Oral candidiasis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Paronychia	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.27% 5/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Pneumonia	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.66% 12/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Pseudomembranous colitis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Pyelonephritis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Pyelonephritis acute	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Sepsis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.33% 6/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Septic shock	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Subcutaneous abscess	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Urinary tract infection	0.40% 5/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Staphylococcal sepsis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Staphylococcal infection	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Neutropenic infection	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Abdominal abscess	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Pneumocystis jiroveci pneumonia	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Device-related infection	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Enterocolitis bacterial	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Infections and infestations Infectious peritonitis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer recurrent	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.27% 5/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	41.8% 524/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	30.4% 557/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Anaemia	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.33% 6/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.93% 17/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.27% 5/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Immune system disorders Anaphylactic reaction	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Immune system disorders Anaphylactic shock	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.27% 5/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Dehydration	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.22% 4/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hyperammonaemia	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hyperkalaemia	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hypocalcaemia	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.38% 7/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hypokalaemia	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hypomagnesaemia	0.64% 8/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.55% 10/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Tetany	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Decreased appetite	0.40% 5/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.87% 16/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hypophagia	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Psychiatric disorders Completed suicide	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Psychiatric disorders Delirium	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Altered state of consciousness	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Bulbar palsy	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Cerebellar haemorrhage	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Cerebral haemorrhage	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Cerebral infarction	0.40% 5/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Convulsion	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.22% 4/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Dizziness	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Dysarthria	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Hepatic encephalopathy	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Hypoaesthesia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Intracranial aneurysm	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Loss of consciousness	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Peripheral neuropathy	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Paralysis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Thrombotic stroke	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Nervous system disorders Tremor	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Eye disorders Cataract	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Eye disorders Conjunctivitis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Eye disorders Periorbital oedema	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Eye disorders Ulcerative keratitis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Ear and labyrinth disorders Vertigo	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Acute myocardial infarction	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Angina pectoris	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Unstable angina	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Myocardial infarction	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Myocardial ischaemia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Prinzmetal angina	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Ventricular fibrillation	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Vascular disorders Aortic dissection	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Vascular disorders Venous thrombosis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Vascular disorders Deep vein thrombosis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Vascular disorders Venous thrombosis limb	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Cardiac disorders Cardiac failure	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Interstitial lung diseases	1.3% 16/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	1.5% 27/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.32% 4/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Respiratory, thoracic and mediastinal disorders Organizing pneumonia	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Abdominal distension	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Abdominal pain	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Ascites	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.22% 4/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Diarrhoea	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	1.4% 26/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Dry mouth	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Duodenal perforation	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Enterocolitis	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Gastric ulcer	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Gastrointestinal perforation	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Glossitis	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Glossodynia	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Ileal perforation	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Ileus	0.48% 6/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.38% 7/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Intestinal obstruction	0.40% 5/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.33% 6/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Malaena	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Nausea	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.27% 5/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Small intestinal performation	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Stomatitis	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	1.3% 24/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Vomiting	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.27% 5/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Subileus	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Large gastrointestinal haemorrhage	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Oral mucosa erosion	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Ileal fistula	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Oral mucosal erythema	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Bile duct stone	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Cholangitis	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Cholangitis acute	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Cholestasis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Hepatic failure	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.22% 4/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Jaundice	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Jaundice cholestatic	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Hepatobiliary disorders Liver disorder	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Acne	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.56% 7/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.76% 14/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Erythema multiforme	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Oculomucocutaneous syndrome	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Rash generalised	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Skin chapped	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Skin erosion	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Skin ulcer	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Musculoskeletal and connective tissue disorders Back pain	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Musculoskeletal and connective tissue disorders Pathological fracture	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Musculoskeletal and connective tissue disorders Spondylitis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Cystitis haemorrhagic	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Hydronephrosis	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Proteinuria	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Renal disorder	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Renal failure	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Renal failure acute	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.22% 4/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Urinary bladder haemorrhage	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Urinary retention	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Renal and urinary disorders Renal impairment	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Chills	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Death	0.24% 3/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.22% 4/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Fatigue	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.11% 2/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Gait disturbance	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Malaise	0.32% 4/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.55% 10/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Multi-organ failure	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Oedema peripheral	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Pyrexia	0.48% 6/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.38% 7/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
General disorders Device occlusion	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Alanine aminotransferase increased	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Aspartate aminotransferase increased	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Blood bilirubin increased	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Blood calcium decreased	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Blood creatinine increased	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Blood magnesium decreased	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Blood potassium increased	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations C-reactive protein increased	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Electrocardiogram QT prolonged	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Neutrophil count decreased	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.71% 13/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations Platelet count descreased	0.16% 2/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations White blood cell count decreased	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.55% 10/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Investigations White blood cell count increased	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Fall	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Femoral neck fracture	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Fractured ischium	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Spinal compression fracture	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.16% 3/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.00% 0/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.08% 1/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.66% 12/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	0.05% 1/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.

Other adverse events

Measure	Panitumumab n=1254 participants at risk Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks	Concomitant Administration of Panitumumab and Chemotherapy n=1831 participants at risk
Infections and infestations Paronychia	21.5% 269/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	25.0% 458/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Metabolism and nutrition disorders Hypomagnesaemia	17.4% 218/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	10.8% 198/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Diarrhoea	2.4% 30/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	8.5% 155/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Gastrointestinal disorders Stomatitis	9.8% 123/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	25.3% 463/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Acne	6.5% 81/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	6.1% 112/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	49.2% 617/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	52.4% 959/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Dry skin	21.1% 265/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	18.8% 344/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.
Skin and subcutaneous tissue disorders Rash	7.8% 98/1254 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.	8.7% 160/1831 • For up to 42 weeks Serious adverse events were tabulated dividing into 2 groups: panitumumab monotherapy or concomitant administration of panitumumab and chemotherapy Serious adverse events grouped by organ system, with number and frequency of such events.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: 800-778-2860

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER