Trial Outcomes & Findings for Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients (NCT NCT01732783)

NCT ID: NCT01732783

Last Updated: 2022-11-08

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 213 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-11-08

Participant Flow

The study was conducted in France and Germany between 10 December 2012 and 30 November 2016.

Participant milestones

Measure	Panitumumab + FOLFOX First-line Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Overall Study STARTED	164	37	12
Overall Study COMPLETED	29	5	2
Overall Study NOT COMPLETED	135	32	10

Reasons for withdrawal

Measure	Panitumumab + FOLFOX First-line Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Overall Study Discontinued Panitumumab Treatment	106	25	7
Overall Study Death	13	4	1
Overall Study Lost to Follow-up	7	1	1
Overall Study Administrative Decision	8	2	1
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Baseline characteristics by cohort

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).	Total n=213 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 9.6 • n=5 Participants	65.8 years STANDARD_DEVIATION 9.9 • n=7 Participants	69.0 years STANDARD_DEVIATION 7.6 • n=5 Participants	65.2 years STANDARD_DEVIATION 9.5 • n=4 Participants
Age, Customized < 65 years	73 Participants n=5 Participants	18 Participants n=7 Participants	2 Participants n=5 Participants	93 Participants n=4 Participants
Age, Customized ≥ 65 to < 75 years	68 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	89 Participants n=4 Participants
Age, Customized ≥ 75 years	23 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	70 Participants n=4 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	24 Participants n=7 Participants	7 Participants n=5 Participants	143 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully active	44 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	55 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Restricted but ambulatory	28 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	42 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Ambulatory but unable to work	8 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Missing	84 Participants n=5 Participants	17 Participants n=7 Participants	5 Participants n=5 Participants	106 Participants n=4 Participants
Primary Colorectal Cancer Type Colon, left of mid-line	54 Participants n=5 Participants	14 Participants n=7 Participants	4 Participants n=5 Participants	72 Participants n=4 Participants
Primary Colorectal Cancer Type Colon, right of mid-line	41 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	56 Participants n=4 Participants
Primary Colorectal Cancer Type Colon	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Primary Colorectal Cancer Type Rectum	66 Participants n=5 Participants	13 Participants n=7 Participants	1 Participants n=5 Participants	80 Participants n=4 Participants
Metastatic Colorectal Cancer Status Synchronous	115 Participants n=5 Participants	20 Participants n=7 Participants	5 Participants n=5 Participants	140 Participants n=4 Participants
Metastatic Colorectal Cancer Status Metachronous	39 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	60 Participants n=4 Participants
Metastatic Colorectal Cancer Status Missing	9 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants
Metastatic Colorectal Cancer Status Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Metastatic Disease Lesion Sites Liver	123 participants n=5 Participants	25 participants n=7 Participants	5 participants n=5 Participants	153 participants n=4 Participants
Metastatic Disease Lesion Sites Lung	36 participants n=5 Participants	13 participants n=7 Participants	4 participants n=5 Participants	53 participants n=4 Participants
Metastatic Disease Lesion Sites Other	56 participants n=5 Participants	11 participants n=7 Participants	4 participants n=5 Participants	71 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Total Number of Panitumumab Infusions	10.0 infusions Interval 6.0 to 16.0	10.0 infusions Interval 6.0 to 16.0	8.0 infusions Interval 4.0 to 15.5

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Cumulative Dose of Panitumumab	4262.5 mg Interval 2311.5 to 6902.5	4000.0 mg Interval 2400.0 to 6000.0	3782.5 mg Interval 1772.5 to 5751.0

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Maximum Dose of Panitumumab	450.0 mg Interval 380.0 to 520.0	420.0 mg Interval 390.0 to 500.0	507.0 mg Interval 424.0 to 590.0

PRIMARY outcome

Timeframe: 12 months

Duration of exposure is the time from the first to the last panitumumab infusion

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Duration of Panitumumab Exposure	5.339 months Interval 2.546 to 10.053	6.012 months Interval 2.464 to 8.246	5.339 months Interval 1.922 to 12.008

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=163 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Mean Interval Between Panitumumab Infusions > 0 to 7 days	0 Participants	0 Participants	0 Participants
Mean Interval Between Panitumumab Infusions > 7 to 14 days	38 Participants	7 Participants	2 Participants
Mean Interval Between Panitumumab Infusions > 14 to 21 days	98 Participants	22 Participants	4 Participants
Mean Interval Between Panitumumab Infusions > 21 to 28 days	21 Participants	8 Participants	5 Participants
Mean Interval Between Panitumumab Infusions > 28 days	6 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Percentage of Participants With at Least One Panitumumab Dose Reduction	36.6 percentage of participants Interval 29.6 to 44.2	21.6 percentage of participants Interval 11.4 to 37.2	50.0 percentage of participants Interval 25.4 to 74.6

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Percentage of Participants With at Least One Panitumumab Dose Delay	42.7 percentage of participants Interval 35.4 to 50.3	21.6 percentage of participants Interval 11.4 to 37.2	41.7 percentage of participants Interval 19.3 to 68.0

PRIMARY outcome

Timeframe: 12 months

Population: Participants who discontinued panitumumab while on study

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=138 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=34 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=8 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Reasons for Discontinuation of Panitumumab Disease progression	35 Participants	12 Participants	3 Participants
Reasons for Discontinuation of Panitumumab Physician or Oncologist decision	30 Participants	7 Participants	0 Participants
Reasons for Discontinuation of Panitumumab Planned surgical resection	16 Participants	1 Participants	0 Participants
Reasons for Discontinuation of Panitumumab Death	12 Participants	3 Participants	1 Participants
Reasons for Discontinuation of Panitumumab Adverse Drug Reaction (ADR)	11 Participants	4 Participants	2 Participants
Reasons for Discontinuation of Panitumumab Patient request to discontinue all treatment	9 Participants	1 Participants	2 Participants
Reasons for Discontinuation of Panitumumab Adverse event	8 Participants	1 Participants	0 Participants
Reasons for Discontinuation of Panitumumab Lost to follow-up	6 Participants	1 Participants	0 Participants
Reasons for Discontinuation of Panitumumab Other	6 Participants	1 Participants	0 Participants
Reasons for Discontinuation of Panitumumab Patient request to discontinue panitumumab	5 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 months

Duration of exposure is the time from the first date to the last date of chemotherapy administration.

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Duration of Exposure of All Concomitant Chemotherapy	5.240 months Interval 2.595 to 8.969	5.092 months Interval 2.431 to 7.622	3.860 months Interval 1.889 to 9.413

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction	43.3 percentage of participants	24.3 percentage of participants	58.3 percentage of participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay	29.3 percentage of participants	29.7 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Number of Participants With at Least One Hospitalization	163 Participants	37 Participants	12 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants with at least one hospital visit

Participants may have had more than one type of hospital visit.

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=163 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Types of Hospital Visit Outpatient	157 participants	35 participants	12 participants
Types of Hospital Visit Inpatient	75 participants	12 participants	6 participants
Types of Hospital Visit Emergency room	11 participants	1 participants	0 participants
Types of Hospital Visit Day case	6 participants	2 participants	0 participants
Types of Hospital Visit Other	6 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants with at least one hospital visit

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=163 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Duration of Hospital Stay	40.0 days Interval 19.0 to 66.0	28.0 days Interval 19.0 to 43.0	24.5 days Interval 8.5 to 60.5

SECONDARY outcome

Timeframe: 12 months

Population: Participants with at least one hospitalization

Participants may have had more than one hospital visit and/or reason for a hospital visit.

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=163 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Reasons for Hospitalization mCRC related	144 participants	30 participants	10 participants
Reasons for Hospitalization Treatment-related	88 participants	16 participants	9 participants
Reasons for Hospitalization mCRC and treatment related	74 participants	14 participants	7 participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants with tumor response data post-baseline

Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=124 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=33 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=8 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Percentage of Participants With an Overall Response	47.6 percentage of participants Interval 38.5 to 56.7	33.3 percentage of participants Interval 18.0 to 51.8	50.0 percentage of participants Interval 15.7 to 84.3

SECONDARY outcome

Timeframe: 12 months

Resectability denotes whether a participant became resectable during the study.

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Number of Participants With Resectability Yes	20 Participants	3 Participants	1 Participants
Number of Participants With Resectability No	135 Participants	33 Participants	7 Participants
Number of Participants With Resectability Unknown	9 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=164 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation	84 participants	15 participants	3 participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants who reported use of anti-cancer treatment after discontinuation of panitumumab

Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.

Outcome measures

Measure	Panitumumab + FOLFOX First-line n=84 Participants Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=15 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=3 Participants Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Type of Post-Panitumumab Anti-cancer Treatment Targeted biologics	5 participants	3 participants	1 participants
Type of Post-Panitumumab Anti-cancer Treatment Chemotherapy	72 participants	10 participants	3 participants
Type of Post-Panitumumab Anti-cancer Treatment Other	10 participants	2 participants	0 participants
Type of Post-Panitumumab Anti-cancer Treatment Radiotherapy	5 participants	0 participants	1 participants
Type of Post-Panitumumab Anti-cancer Treatment Other small molecules	0 participants	1 participants	0 participants

Adverse Events

Panitumumab + FOLFOX First-line

Serious events: 10 serious events

Other events: 101 other events

Deaths: 0 deaths

Panitumumab + FOLFIRI Second-line

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Panitumumab + FOLFIRI First-line

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panitumumab + FOLFOX First-line n=164 participants at risk Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 participants at risk Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 participants at risk Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Cardiac disorders Angina pectoris	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	1.2% 2/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dyspepsia	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	1.2% 2/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Inflammation of wound	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Eastern Cooperative Oncology Group performance status worsened	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 2/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatosis	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	1.2% 2/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Collapse circulatory	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Panitumumab + FOLFOX First-line n=164 participants at risk Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).	Panitumumab + FOLFIRI Second-line n=37 participants at risk Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).	Panitumumab + FOLFIRI First-line n=12 participants at risk Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).
Gastrointestinal disorders Diarrhoea	4.3% 7/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.3% 1/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Stomatitis	0.61% 1/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.7% 1/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.3% 1/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Mucosal inflammation	6.1% 10/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.4% 2/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 2/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Conjunctivitis	1.2% 2/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.1% 3/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis	6.1% 10/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.7% 1/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dry skin	4.3% 7/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.1% 3/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	48.8% 80/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	56.8% 21/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 6/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin fissures	4.9% 8/164 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.4% 2/37 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/12 • From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively. Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER