Measure Type	Primary
Measure Title	Percentage of Participants With an Overall Resonse
Measure Description	Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.
Time Frame	Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The overall response rate was calculated for the modified Intent to Treat (mITT) population.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Percentage of Participants With an Overall Resonse [units: percentage of participants] Mean ( 95% Confidence Interval )	8.2 ( 3.4 to 16.2 )

No statistical analysis provided for Percentage of Participants With an Overall Resonse

Measure Type	Primary
Measure Title	Number of Participants With Adverse Events
Measure Description	Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).
Time Frame	An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Number of Participants With Adverse Events [units: Participants]	85

No statistical analysis provided for Number of Participants With Adverse Events

Measure Type	Primary
Measure Title	Number of Participants With Serious Adverse Events
Measure Description	Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, was life threatening, required inpatient hospitalization or caused prolongation of existing hospitalization,congenital anomaly/birth defect, or any important medical event.
Time Frame	A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Number of Participants With Serious Adverse Events [units: Participants]	19

No statistical analysis provided for Number of Participants With Serious Adverse Events

Measure Type	Secondary
Measure Title	Percentage of Participants With Disease Control (CR, PR, or SD)
Measure Description	This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated.
Time Frame	Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Disease control rate was the total number of patients with best overall response of CR, PR and SD divided by the total number of patients treated.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Percentage of Participants With Disease Control (CR, PR, or SD) [units: Percentage of participants] Mean ( 95% Confidence Interval )	49.4 ( 38.4 to 60.5 )

No statistical analysis provided for Percentage of Participants With Disease Control (CR, PR, or SD)

Measure Type	Secondary
Measure Title	Duration of Response
Measure Description	In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of response of living patients with no evidence of PD was censored on the date of their last tumor assessment.
Time Frame	The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months).
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The duration of response was calculated for the subgroup of the mITT population who demonstrated a response.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	7
Duration of Response [units: Months] Median ( 95% Confidence Interval )	5.1 ( 2.7 to 6.9 )

No statistical analysis provided for Duration of Response

Measure Type	Secondary
Measure Title	Time to Progression
Measure Description	This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment.
Time Frame	Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months).
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This measure was calculated for the mITT population.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Time to Progression [units: Months] Median ( 95% Confidence Interval )	2.5 ( 1.3 to 2.8 )

No statistical analysis provided for Time to Progression

Measure Type	Secondary
Measure Title	Overall Survival
Measure Description	This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive.
Time Frame	Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Overall survival was calculated from the time of the first day of therapy to the date of death for the mITT population.

Reporting Groups

	Description
Cetuximab	Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Measured Values

	Cetuximab
Number of Participants Analyzed [units: participants]	85
Overall Survival [units: Months] Median ( 95% Confidence Interval )	10.0 ( 7.5 to 12.0 )

No statistical analysis provided for Overall Survival