Cetuximab (Erbitux) in Combination With Cisplatin or Carb... | NCT00122460

Label	Type	Description	Intervention Names
Cetuximab Plus Chemotherapy	Experimental		Drug: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)
Chemotherapy alone	Active Comparator		Drug: Platinum (Cisplatin or Carboplatin) + 5-FU

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)	Drug	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks

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, whatever is earlier.	time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Measure	Description	Time Frame
Progression-free Survival Time (PFS)	Duration from randomization until radiological progression according to investigator (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 randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Name	Affiliation	Role
Medical Responsible	Merck KGaA, Darmstadt, Germany	Study Director

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

PubMed Identifier	Type	Citation	Retractions
18784101	Result	Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
20335368

ID	Title	Description
FG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

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

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, whatever is earlier.

Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized).

Analysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007.

Posted

Median

95% Confidence Interval

months

time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Units	Counts
Participants	OG000222 OG001220

Title

Denominators

Categories

Title	Measurements
	OG00010.1(8.6 to 11.2) OG0017.4(6.4 to 8.3)

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 primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) [no vs. yes] and Karnofsky Performance Status (KPS) [<80 vs. ≥80]). Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata.	Stratified Log Rank		0.036		Hazard Ratio (HR)	0.797			2-Sided	95	0.644	0.986				No	Superiority or Other

Secondary

Progression-free Survival Time (PFS)

Duration from randomization until radiological progression according to investigator (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.

Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.

Posted

Median

95% Confidence Interval

months

time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Secondary

Best Overall Response

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 according to investigator (based on modified WHO criteria).

Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.

Posted

Number

95% Confidence Interval

percentage of participants

evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Secondary

Disease Control

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 according to investigator (based on modified WHO criteria).

Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.

Posted

Number

95% Confidence Interval

percentage of participants

evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Secondary

Time to Treatment Failure

Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).

Patients without event are censored on the date of last tumor assessment.

Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.

Posted

Median

95% Confidence Interval

months

Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

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.

Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.

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, 21 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

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.

Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22

Posted

Least Squares Mean

Standard Error

scores on a scale

at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone

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 social functioning.

Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23

Posted

Least Squares Mean

Standard Error

scores on a scale

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone

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 dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
OG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected219 at risk EG00110 affected215 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected219 at risk EG0019 affected215 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0015 affected215 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected219 at risk EG00110 affected215 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG0016 affected215 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Angina unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Arrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Cardiac arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0012 affected215 at risk
Cardiac failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Keratitis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0012 affected215 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0012 affected215 at risk
Aphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Colitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG0012 affected215 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0012 affected215 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Ileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Melaena	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Oral pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Stress ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Subileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected219 at risk EG0014 affected215 at risk
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Face oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG0012 affected215 at risk
General physical health deterioration	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected219 at risk EG0012 affected215 at risk
Hyperthermia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Mucosal inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected219 at risk EG0016 affected215 at risk
Multi-organ failure	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Oedema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Oedema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Performance status decreased	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0014 affected215 at risk
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0017 affected215 at risk
Sudden death	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Hypersensitivity	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG0010 affected215 at risk
Abscess neck	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Bronchopneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Catheter related infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Catheter sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Central line infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Erysipelas	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0012 affected215 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Lung infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Lymph gland infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Meningitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Pharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00010 affected219 at risk EG0014 affected215 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Pyothorax	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0012 affected215 at risk
Salmonella sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 affected219 at risk EG0011 affected215 at risk
Septic shock	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected219 at risk EG0010 affected215 at risk
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Thrombophlebitis septic	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Feeding tube complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Gastrostomy failure	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Blood creatinine increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Creatinine renal clearance decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Haemoglobin	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Haemoglobin decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0014 affected215 at risk
Neurological examination abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Oxygen saturation decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Platelet count decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Transaminases increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Urine electrolytes decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0013 affected215 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected219 at risk EG0010 affected215 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected219 at risk EG0013 affected215 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0013 affected215 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG0010 affected215 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG0010 affected215 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0012 affected215 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0017 affected215 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Brain oedema	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Cerebral infarction	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Coma	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0013 affected215 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0010 affected215 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Intracranial hypotension	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0013 affected215 at risk
Confusional state	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0013 affected215 at risk
Suicide attempt	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Renal failure	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0012 affected215 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected219 at risk EG0013 affected215 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected219 at risk EG00111 affected215 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected219 at risk EG0011 affected215 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0012 affected215 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0012 affected215 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0012 affected215 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0015 affected215 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected219 at risk EG0011 affected215 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Gastrostomy tube insertion	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Medical device removal	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Aortic aneurysm	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Haemorrhage	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0012 affected215 at risk
Ischaemia	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Shock	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0011 affected215 at risk
Thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected219 at risk EG0011 affected215 at risk
Wound haemorrhage	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected219 at risk EG0010 affected215 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	EG00092 affected219 at risk EG001111 affected215 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00083 affected219 at risk EG00177 affected215 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00046 affected219 at risk EG00148 affected215 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00041 affected219 at risk EG00132 affected215 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00016 affected219 at risk EG00113 affected215 at risk
Conjunctivitis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected219 at risk EG0010 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG000119 affected219 at risk EG001100 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00084 affected219 at risk EG00179 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00056 affected219 at risk EG00133 affected215 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00048 affected219 at risk EG00143 affected215 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00031 affected219 at risk EG00128 affected215 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected219 at risk EG00119 affected215 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected219 at risk EG0017 affected215 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected219 at risk EG0017 affected215 at risk
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00056 affected219 at risk EG00147 affected215 at risk
Mucosal inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG00050 affected219 at risk EG00138 affected215 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00049 affected219 at risk EG00144 affected215 at risk
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00048 affected219 at risk EG00123 affected215 at risk
General physical health deterioration	General disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected219 at risk EG0012 affected215 at risk
Paronychia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00019 affected219 at risk EG0010 affected215 at risk
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG00041 affected219 at risk EG00130 affected215 at risk
Platelet count decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG00013 affected219 at risk EG0017 affected215 at risk
Blood creatinine increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG00011 affected219 at risk EG00113 affected215 at risk
Haemoglobin decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0009 affected219 at risk EG00111 affected215 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00054 affected219 at risk EG00131 affected215 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00026 affected219 at risk EG00110 affected215 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00025 affected219 at risk EG00115 affected215 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected219 at risk EG00111 affected215 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected219 at risk EG00117 affected215 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected219 at risk EG00111 affected215 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG00019 affected219 at risk EG00119 affected215 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00020 affected219 at risk EG00115 affected215 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00014 affected219 at risk EG0018 affected215 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected219 at risk EG00111 affected215 at risk
Insomnia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00020 affected219 at risk EG0017 affected215 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected219 at risk EG00119 affected215 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected219 at risk EG00119 affected215 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected219 at risk EG00112 affected215 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00061 affected219 at risk EG0014 affected215 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00048 affected219 at risk EG0010 affected215 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00032 affected219 at risk EG0010 affected215 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00030 affected219 at risk EG0011 affected215 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00027 affected219 at risk EG00115 affected215 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected219 at risk EG0010 affected215 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00017 affected219 at risk EG0010 affected215 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected219 at risk EG0010 affected215 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected219 at risk EG00110 affected215 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00014 affected219 at risk EG0019 affected215 at risk
Phlebitis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected219 at risk EG0015 affected215 at risk

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
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements
D008670	Metals
D017606	Chlorine Compounds
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
BG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
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 Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.			110	219	214	219
EG001	Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.			102	215	198	215

ID	Term
D000068818	Cetuximab
D010984	Platinum
D002945	Cisplatin
D016190	Carboplatin
D005472	Fluorouracil