Cetuximab Combined With Irinotecan in First-line Therapy... | NCT00154102

NCT00154102

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cetuximab Plus FOLFIRI	Experimental		Drug: Cetuximab Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
FOLFIRI Alone	Active Comparator		Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Number of Cycles: until progression or unacceptable toxicity develops

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments	Duration from randomization until radiological progression (based on modified World Health Organisation (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.	Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments	Duration from randomization until radiological progression (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.	Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments	Duration from randomization until radiological progression (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.	Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival Time (OS)	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, whichever is later.	Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009

Eligibility Module

Name	Affiliation	Role
Eric van Cutsem, Professor	University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Buenos Aires			Argentina
Research Site

References Module

Citations

PubMed Identifier	Type	Citation
19339720	Result	Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.
	Result	Van Cutsem E, Lang I, Folprecht G, Nowacki M, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Celik I, Kohne C Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): The influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO 2010 Gastrointestinal Cancers Symposium, Orlando, USA January 2010 Abstract No: 281
	Result	Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Zubel A, Van Cutsem E Cetuximab plus FOLFIRI in 1st-line treatment of metastatic colorectal cancer: Quality of life (QoL) analysis of patients (pts) with KRAS wild-type (wt) tumours in the CRYSTAL trial. European Journal of Cancer Supplements. 2009 7(2):345

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
BG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age missing for 1 subject

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.0± 10.52 BG00159.8± 11.06 BG00259.9± 10.79

Age, Customized

Age missing for 1 subject

Number

participants

Title

Denominators

Categories

Missing

Title	Measurements
	BG0001 BG0010 BG002

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000230 BG001243 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Western Europe

Title	Measurements
	BG000262 BG001267 BG002

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

Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments

Duration from randomization until radiological progression (based on modified World Health Organisation (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 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

Median

95% Confidence Interval

months

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Units	Counts
Participants	OG000599 OG001599

Title

Denominators

Categories

Title	Measurements
	OG0008.9(8.0 to 9.4) OG0018.0(7.6 to 9.0)

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	The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):<80 vs. ≥80)	Stratified log rank	Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.	0.0479		Hazard Ratio (HR)	0.853			2-Sided	95	0.728	1.000				No

Primary

Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments

Duration from randomization until radiological progression (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.

Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009

Posted

Median

95% Confidence Interval

months

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Primary

Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments

Duration from randomization until radiological progression (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.

Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009

Posted

Median

95% Confidence Interval

months

Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Overall Survival Time (OS)

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, whichever is later.

ITT population (allocation to treatment groups as randomized and treated)

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, 10 Aug 2004, until cut-off date, 31 May 2009

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

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, whichever is later.

Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009

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, 10 Aug 2004, until cut-off date, 31 May 2009

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

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, whichever is later.

Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009

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, 10 Aug 2004, until cut-off date, 31 May 2009

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Best Overall Response Rate - Independent Review Committee (IRC) Assessments

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).

ITT population (allocation to treatment groups as randomized and treated)

Posted

Number

95% Confidence Interval

percentage of participants

evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments

Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009

Posted

Number

95% Confidence Interval

percentage participants

evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments

Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009

Posted

Number

95% Confidence Interval

percentage of participants

evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Disease Control Rate - Independent Review Committee (IRC) Assessments

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 (based on modified WHO criteria).

ITT population (allocation to treatment groups as randomized and treated)

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Duration of Response - Independent Review Committee (IRC) Assessments

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.

ITT population (allocation to treatment groups as randomized and treated)

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, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Participants With No Residual Tumor After Metastatic Surgery

Participants with no residual tumor after on-study surgery for metastases

ITT population (allocation to treatment groups as randomized and treated)

Posted

Number

Participants

time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Units	Counts

Secondary

Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.

1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire & were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96

Posted

Least Squares Mean

Standard Error

scores on a scale

at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Secondary

Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.

1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population

Posted

Least Squares Mean

Standard Error

scores on a scale

at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

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 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007

ID	Title	Description
OG000	Cetuximab Plus FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
OG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

Units	Counts
Participants

Arm/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 FOLFIRI	Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.			263	600	593	600
EG001	FOLFIRI Alone	Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects			204	602	591	602

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0018 affected602 at risk
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG00016 affected600 at risk EG00113 affected602 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0006 affected600 at risk EG0017 affected602 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG00037 affected600 at risk EG00135 affected602 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
PLATELET TOXICITY	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0011 affected602 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ARTERIOSPASM CORONARY	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0012 affected602 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0011 affected602 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CONDUCTION DISORDER	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0011 affected602 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0011 affected602 at risk
PALPITATIONS	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
RIGHT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
DIABETES INSIPIDUS	Endocrine disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG00014 affected600 at risk EG00113 affected602 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0012 affected602 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ANAL FISTULA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ASCITES	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0013 affected602 at risk
COLONIC OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0006 affected600 at risk EG0012 affected602 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG00036 affected600 at risk EG00121 affected602 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ENTEROVESICAL FISTULA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
GASTRO-INTESTINAL FISTULA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
GASTROINTESTINAL HYPOMOTILITY	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
GASTROINTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
ILEUS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG00010 affected600 at risk EG0017 affected602 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0007 affected600 at risk EG0018 affected602 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
MESENTERIC VEIN THROMBOSIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0008 affected600 at risk EG0015 affected602 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PERITONEAL EFFUSION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
PERITONITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0012 affected602 at risk
PROCTALGIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0014 affected602 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0012 affected602 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0018 affected602 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment		EG00015 affected600 at risk EG00116 affected602 at risk
ASTHENIA	General disorders	MedDRA 10.0	Systematic Assessment		EG0006 affected600 at risk EG0015 affected602 at risk
CATHETER RELATED COMPLICATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
CATHETER SITE HAEMATOMA	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CATHETER SITE INFLAMMATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
CATHETER SITE PAIN	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CHEST PAIN	General disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0012 affected602 at risk
CHILLS	General disorders	MedDRA 10.0	Systematic Assessment		EG0005 affected600 at risk EG0012 affected602 at risk
DEATH	General disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
DISEASE PROGRESSION	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
EXTRAVASATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
FATIGUE	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0018 affected602 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0011 affected602 at risk
INFLAMMATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
INFUSION SITE EXTRAVASATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
INFUSION SITE PAIN	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
LOCALISED OEDEMA	General disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0012 affected602 at risk
PYREXIA	General disorders	MedDRA 10.0	Systematic Assessment		EG00026 affected600 at risk EG00121 affected602 at risk
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
BILIARY FISTULA	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
DILATATION INTRAHEPATIC DUCT ACQUIRED	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0010 affected602 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ABDOMINAL INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ABSCESS INTESTINAL	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
APPENDICITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
BACTERAEMIA	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CATHETER RELATED INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0008 affected600 at risk EG0011 affected602 at risk
CATHETER SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CELLULITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG00010 affected600 at risk EG0014 affected602 at risk
ERYSIPELAS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0011 affected602 at risk
LISTERIOSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0013 affected602 at risk
LUNG ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
NEUTROPENIC INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
OTITIS MEDIA CHRONIC	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PELVIC ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
PERIANAL ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0009 affected600 at risk EG0017 affected602 at risk
PNEUMONIA KLEBSIELLA	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
POSTOPERATIVE INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
RETROPERITONEAL ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0011 affected602 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
SINUSITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
SKIN INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0013 affected602 at risk
VARICELLA	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
WOUND INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ANASTOMOTIC STENOSIS	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
FRACTURED SACRUM	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0011 affected602 at risk
INTESTINAL STOMA COMPLICATION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0012 affected602 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
POST PROCEDURAL BILE LEAK	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
STENT OCCLUSION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
VASCULAR ACCESS COMPLICATION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
LABORATORY TEST ABNORMAL	Investigations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
URINE ANALYSIS ABNORMAL	Investigations	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
WEIGHT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0014 affected602 at risk
CACHEXIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG00016 affected600 at risk EG00112 affected602 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0012 affected602 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG00013 affected600 at risk EG0011 affected602 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
MALNUTRITION	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
ORAL INTAKE REDUCED	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0012 affected602 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0012 affected602 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
TUMOUR ASSOCIATED FEVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
TUMOUR HAEMORRHAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
COMA	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CONVULSION	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
COORDINATION ABNORMAL	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
EPILEPSY	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
LETHARGY	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
SYNCOPE	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0012 affected602 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
VOCAL CORD PARALYSIS	Nervous system disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ACUTE CARDIO-VASCULAR INSUFFICIENCY	Cardiac disorders	MedDRA 10.0	Systematic Assessment	An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report	EG0000 affected600 at risk EG0011 affected602 at risk
ACUTE GASTROENTERITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report	EG0000 affected600 at risk EG0011 affected602 at risk
ACUTE PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report	EG0001 affected600 at risk EG0010 affected602 at risk
CIRCULATORY INSUFFICIENCY	Cardiac disorders	MedDRA 10.0	Systematic Assessment	An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report	EG0001 affected600 at risk EG0010 affected602 at risk
INFECTION OF OSTEOSYNTHESIS IN RIGHT ANCLE	Infections and infestations	MedDRA 10.0	Systematic Assessment	An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report	EG0001 affected600 at risk EG0010 affected602 at risk
THROMBUS//CLOT IN VEIN OF LEFT HAND CAUSING INFECTION	General disorders	MedDRA 10.0	Systematic Assessment	An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report	EG0001 affected600 at risk EG0010 affected602 at risk
ABNORMAL BEHAVIOUR	Psychiatric disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0012 affected602 at risk
EUPHORIC MOOD	Psychiatric disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
CALCULUS URINARY	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
DYSURIA	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HAEMORRHAGE URINARY TRACT	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0011 affected602 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0011 affected602 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
VAGINAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0007 affected600 at risk EG0014 affected602 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0003 affected600 at risk EG0010 affected602 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG00020 affected600 at risk EG00110 affected602 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0011 affected602 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0010 affected602 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0011 affected602 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CATARACT OPERATION	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
AXILLARY VEIN THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0009 affected600 at risk EG0015 affected602 at risk
EMBOLISM	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
HYPOTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0005 affected600 at risk EG0013 affected602 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
ISCHAEMIA	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
JUGULAR VEIN THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
PERIPHERAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
PHLEBITIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
SUBCLAVIAN VEIN THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0000 affected600 at risk EG0011 affected602 at risk
THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0004 affected600 at risk EG0014 affected602 at risk
VENA CAVA THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0002 affected600 at risk EG0011 affected602 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 10.0	Systematic Assessment		EG0001 affected600 at risk EG0010 affected602 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG000272 affected600 at risk EG001249 affected602 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG000127 affected600 at risk EG001120 affected602 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG000121 affected600 at risk EG001127 affected602 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00031 affected600 at risk EG00120 affected602 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected600 at risk EG00135 affected602 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA 10.0	Systematic Assessment	EG00088 affected600 at risk EG00113 affected602 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000377 affected600 at risk EG001353 affected602 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000322 affected600 at risk EG001359 affected602 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000194 affected600 at risk EG001231 affected602 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000169 affected600 at risk EG001110 affected602 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000142 affected600 at risk EG001154 affected602 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000135 affected600 at risk EG001119 affected602 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00078 affected600 at risk EG00146 affected602 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00045 affected600 at risk EG00133 affected602 at risk
FATIGUE	General disorders	MedDRA 10.0	Systematic Assessment	EG000192 affected600 at risk EG001186 affected602 at risk
PYREXIA	General disorders	MedDRA 10.0	Systematic Assessment	EG000136 affected600 at risk EG00164 affected602 at risk
ASTHENIA	General disorders	MedDRA 10.0	Systematic Assessment	EG000110 affected600 at risk EG001112 affected602 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 10.0	Systematic Assessment	EG00082 affected600 at risk EG00153 affected602 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 10.0	Systematic Assessment	EG00048 affected600 at risk EG00142 affected602 at risk
INJECTION SITE REACTION	General disorders	MedDRA 10.0	Systematic Assessment	EG00040 affected600 at risk EG00138 affected602 at risk
PARONYCHIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG000107 affected600 at risk EG0013 affected602 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00030 affected600 at risk EG00135 affected602 at risk
WEIGHT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG00094 affected600 at risk EG00152 affected602 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG000169 affected600 at risk EG001149 affected602 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00058 affected600 at risk EG00130 affected602 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00042 affected600 at risk EG0013 affected602 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00038 affected600 at risk EG00155 affected602 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00030 affected600 at risk EG00123 affected602 at risk
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00064 affected600 at risk EG00155 affected602 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00043 affected600 at risk EG00140 affected602 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00041 affected600 at risk EG00145 affected602 at risk
INSOMNIA	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00057 affected600 at risk EG00153 affected602 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00064 affected600 at risk EG00159 affected602 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00053 affected600 at risk EG00132 affected602 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00050 affected600 at risk EG00127 affected602 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG000270 affected600 at risk EG00123 affected602 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG000224 affected600 at risk EG001229 affected602 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG000146 affected600 at risk EG0012 affected602 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG000133 affected600 at risk EG00130 affected602 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG000101 affected600 at risk EG00127 affected602 at risk
SKIN FISSURES	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00097 affected600 at risk EG00110 affected602 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00073 affected600 at risk EG00128 affected602 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00069 affected600 at risk EG0011 affected602 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00054 affected600 at risk EG0015 affected602 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00040 affected600 at risk EG00112 affected602 at risk
EXFOLIATIVE RASH	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00035 affected600 at risk EG0013 affected602 at risk
SKIN TOXICITY	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00034 affected600 at risk EG0011 affected602 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00046 affected600 at risk EG00136 affected602 at risk
PHLEBITIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00038 affected600 at risk EG00120 affected602 at risk
HYPOTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00032 affected600 at risk EG00120 affected602 at risk

Ancestor Terms

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
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D002166	Camptothecin
D000470	Alkaloids

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D000068818	Cetuximab
D005472	Fluorouracil
D002955	Leucovorin
D000077146	Irinotecan