Oxaliplatin and Cetuximab in First-line Treatment of Meta... | NCT00125034

Label	Type	Description	Intervention Names
Cetuximab Plus FOLFOX-4	Experimental		Biological: Cetuximab
FOLFOX-4 Alone	Active Comparator		Drug: Oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Biological	Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops

Measure	Description	Time Frame
Best Overall Response Rate - Independent Review Committee (IRC)	The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006

Measure	Description	Time Frame
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)	The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.	Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007

Name	Affiliation	Role
Bokemeyer, Prof. Dr.	Klinik für Onkologie, Hämatologie und Knochenmarktransplantationen Universitätsklinikum Hamburg-Eppendorf, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Graz			Austria
Research Site

PubMed Identifier	Type	Citation	Retractions
19114683	Result	Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):663-71. doi: 10.1200/JCO.2008.20.8397. Epub 2008 Dec 29.
21228335

ID	Title	Description
FG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Best Overall Response Rate - Independent Review Committee (IRC)

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.

Primary analysis on the Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Units	Counts
Participants	OG000169 OG001168

Title

Denominators

Categories

Title	Measurements
	OG00045.6(37.9 to 53.4) OG00135.7(28.5 to 43.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 & 50% under FOLFOX-4 alone for the stratum with ECOG PS0-1 & 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%	stratified Cochran-Mantel-Haenszel test	Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.	0.064		Odds Ratio (OR)	1.516			2-Sided	95	0.975	2.335				No

Secondary

Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)

KRAS Wild-Type population

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Best Overall Response Rate (KRAS Mutant Population)

KRAS Mutant population

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Progression-free Survival Time

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.

Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).

Posted

Median

95% Confidence Interval

months

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Progression-free Survival Time (KRAS Wild-Type Population)

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.

KRAS Wild-Type population

Posted

Median

95% Confidence Interval

months

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Progression-free Survival Time (KRAS Mutant Population)

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.

KRAS Mutant population

Posted

Median

95% Confidence Interval

months

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Overall Survival Time

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).

Posted

Median

95% Confidence Interval

months

Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Overall Survival Time (KRAS Wild-Type Population)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

KRAS Wild-Type population

Posted

Median

95% Confidence Interval

months

Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Overall Survival Time (KRAS Mutant Population)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

KRAS Mutant population

Posted

Median

95% Confidence Interval

months

Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Participants With No Residual Tumor After Metastatic Surgery

No residual tumor after on-study surgery for metastases.

Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).

Posted

Number

participants

Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Disease Control Rate (Cut Off Date 4 August 2006)

The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).

Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Duration of Response

Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).

Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.

Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).

Posted

Median

95% Confidence Interval

months

Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Secondary

Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details

Safety Population

Posted

Number

participants

time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008

ID	Title	Description
OG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
OG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected170 at risk EG0013 affected168 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected170 at risk EG0012 affected168 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected170 at risk EG0015 affected168 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0011 affected168 at risk
ASCITES	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
COLITIS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0012 affected168 at risk
GASTROINTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
ILEUS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected170 at risk EG0011 affected168 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected170 at risk EG0010 affected168 at risk
LARGE INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
PERITONITIS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
RECTAL STENOSIS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
VOMITING	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0014 affected168 at risk
ASTHENIA	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected170 at risk EG0011 affected168 at risk
CHEST PAIN	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
FATIGUE	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0011 affected168 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
INJECTION SITE REACTION	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
MASS	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
OBSTRUCTION	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
PYREXIA	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected170 at risk EG0014 affected168 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HEPATORENAL SYNDROME	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected170 at risk EG0012 affected168 at risk
ABSCESS NECK	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
BRONCHITIS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
CATHETER RELATED INFECTION	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
ERYSIPELAS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
FEBRILE INFECTION	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
INFECTION	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0011 affected168 at risk
KIDNEY INFECTION	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
LUNG ABSCESS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
PERITONITIS BACTERIAL	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
PNEUMONIA	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected170 at risk EG0013 affected168 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
SEPSIS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
TUBERCULOSIS	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected170 at risk EG0010 affected168 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0011 affected168 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
DIZZINESS	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
EPILEPSY	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
SYNCOPE	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
ALCOHOLIC PSYCHOSIS	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
MEDIASTINAL HAEMATOMA	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected170 at risk EG0012 affected168 at risk
TACHYPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
ILEOCOLOSTOMY	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
AXILLARY VEIN THROMBOSIS	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
EMBOLISM	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
HYPERTENSION	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected170 at risk EG0010 affected168 at risk
HYPOTENSION	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk
THROMBOPHLEBITIS	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected170 at risk EG0011 affected168 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected170 at risk EG0010 affected168 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00044 affected170 at risk EG00141 affected168 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00049 affected170 at risk EG00143 affected168 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00077 affected170 at risk EG00184 affected168 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00045 affected170 at risk EG00169 affected168 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected170 at risk EG0017 affected168 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG00023 affected170 at risk EG0018 affected168 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00030 affected170 at risk EG00129 affected168 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00032 affected170 at risk EG00116 affected168 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00081 affected170 at risk EG00168 affected168 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected170 at risk EG0019 affected168 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00069 affected170 at risk EG00165 affected168 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00033 affected170 at risk EG00119 affected168 at risk
VOMITING	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00048 affected170 at risk EG00137 affected168 at risk
ASTHENIA	General disorders	MedDRA (10.0)	Systematic Assessment	EG00032 affected170 at risk EG00131 affected168 at risk
FATIGUE	General disorders	MedDRA (10.0)	Systematic Assessment	EG00054 affected170 at risk EG00143 affected168 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected170 at risk EG0018 affected168 at risk
PYREXIA	General disorders	MedDRA (10.0)	Systematic Assessment	EG00039 affected170 at risk EG00130 affected168 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected170 at risk EG0011 affected168 at risk
PARONYCHIA	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00020 affected170 at risk EG0010 affected168 at risk
WEIGHT DECREASED	Investigations	MedDRA (10.0)	Systematic Assessment	EG00026 affected170 at risk EG00119 affected168 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00034 affected170 at risk EG00123 affected168 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected170 at risk EG0010 affected168 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected170 at risk EG0015 affected168 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00016 affected170 at risk EG0012 affected168 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected170 at risk EG0018 affected168 at risk
DIZZINESS	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected170 at risk EG0013 affected168 at risk
HEADACHE	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected170 at risk EG0018 affected168 at risk
NEUROPATHY	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected170 at risk EG00116 affected168 at risk
NEUROTOXICITY	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected170 at risk EG0017 affected168 at risk
PARAESTHESIA	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected170 at risk EG00138 affected168 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00046 affected170 at risk EG00151 affected168 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected170 at risk EG0015 affected168 at risk
INSOMNIA	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected170 at risk EG0016 affected168 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected170 at risk EG0017 affected168 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected170 at risk EG00111 affected168 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected170 at risk EG0010 affected168 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected170 at risk EG00117 affected168 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00038 affected170 at risk EG0011 affected168 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00028 affected170 at risk EG0013 affected168 at risk
EXFOLIATIVE RASH	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected170 at risk EG0010 affected168 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected170 at risk EG0012 affected168 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected170 at risk EG0017 affected168 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected170 at risk EG0016 affected168 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00090 affected170 at risk EG0014 affected168 at risk
SKIN FISSURES	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00017 affected170 at risk EG0010 affected168 at risk
SKIN TOXICITY	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected170 at risk EG0010 affected168 at risk
HYPERTENSION	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected170 at risk EG0018 affected168 at risk

ID	Term
D009362	Neoplasm Metastasis
D015179	Colorectal Neoplasms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description
BG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
BG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cetuximab Plus FOLFOX-4	Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.			61	170	170	170
EG001	FOLFOX-4 Alone	5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.			43	168	165	168