Erbitux in Combination With Xeloda and Cisplatin in Advan... | NCT00678535

NCT00678535

ID	Type	Description	Link
2007-004219-75	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Cetuximab plus Capecitabine plus Cisplatin	Experimental		Drug: Cetuximab Drug: Capecitabine Drug: Cisplatin
Capecitabine plus Cisplatin	Active Comparator		Drug: Capecitabine Drug: Cisplatin

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	Single first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments	The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants 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 participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	The OS time is defined as the time from randomization to death or last day known to be alive. Participants 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 participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent before any study-related activities are carried out
Age greater than or equal to (>=) 18 years
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to Siewert classification)
Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
Unresectable advanced (M0) or unresectable metastatic (M1) disease
At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Estimated life expectancy greater than (>) 12 weeks
Medically accepted contraception (if the risk of conception exists)
Glomerular filtration rate (GFR) >= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance
Aspartate-aminotransferase (ASAT) less than or equal to (=<) 2.5 * upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =< 2.5 *ULN
Bilirubin =< 3 * ULN
Absolute neutrophil count (ANC) >= 1.5 * 10^9 per liter
Platelets >= 100 * 10^9 per liter
Hemoglobin >=10 gram per deciliter (g/dL) (without transfusions)
Sodium and potassium within normal limits or =< 10 percent above or below (supplementation permitted)

Exclusion Criteria:

Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m^2 cisplatin has been administered
Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways
Brain metastasis and/or leptomeningeal disease (known or suspected)
Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment
Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)
Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia
Active Hepatitis B or C
Chronic diarrhea or short bowel syndrome
Presence of any contra-indication to treatment with cetuximab, capecitabine and cisplatin including:
- Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Current treatment with sorivudine or chemically related analogues, such as brivudine
- Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >= 2 and/or ototoxicity NCI CTCAE Grade >= 2, except if due to trauma or mechanical impairment due to tumor mass
Pregnancy or lactation period
Concurrent treatment with a non-permitted drug
Treatment in another clinical study within 30 days prior to study screening
Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive cancer of the cervix
Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
Legal incapacity or limited legal capacity
Significant disease which, in the Investigator's opinion, would exclude the subject from the study

Name	Affiliation	Role
Florian Lordick, MD, PhD	University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Rosario			Argentina
Research site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.

Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.

Posted

Median

95% Confidence Interval

months

Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

ID	Title	Description
OG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000455 OG001449

Title

Denominators

Categories

Title	Measurements
	OG0004.4(4.2 to 5.5) OG0015.6(5.1 to 5.7)

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	Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).	Stratified log rank		0.3158		Hazard Ratio (HR)	1.091				95	0.920	1.292			Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.	No	Superiority or Other

Secondary

Overall Survival (OS)

The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

ITT population included all participants who were randomized to trial treatment.

Posted

Median

95% Confidence Interval

months

Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)

ID	Title	Description
OG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments

The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC.

ITT population included all participants who were randomized to trial treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)

ID	Title	Description
OG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Mean global health status and 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 better QoL.

Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

ID	Title	Description
OG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire

EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.

Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

ID	Title	Description
OG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Capecitabine Plus Cisplatin

Secondary

Safety - Number of Participants With Adverse Events (AEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.

The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.

Posted

Number

participants

Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)

ID	Title	Description
OG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG00010 affected446 at risk EG00117 affected436 at risk
Neutropenia	Blood and lymphatic system disorders	EG0009 affected446 at risk EG00113 affected436 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG0005 affected446 at risk EG0015 affected436 at risk
Leukopenia	Blood and lymphatic system disorders	EG0003 affected446 at risk EG0017 affected436 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0002 affected446 at risk EG0016 affected436 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Granulocytopenia	Blood and lymphatic system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Acute myocardial infarction	Cardiac disorders	EG0004 affected446 at risk EG0012 affected436 at risk
Cardiac arrest	Cardiac disorders	EG0003 affected446 at risk EG0011 affected436 at risk
Myocardial infarction	Cardiac disorders	EG0003 affected446 at risk EG0012 affected436 at risk
Atrial fibrillation	Cardiac disorders	EG0002 affected446 at risk EG0012 affected436 at risk
Cardio-respiratory arrest	Cardiac disorders	EG0002 affected446 at risk EG0014 affected436 at risk
Myocardial ischaemia	Cardiac disorders	EG0002 affected446 at risk EG0013 affected436 at risk
Acute coronary syndrome	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Angina pectoris	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Atrial flutter	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Cardiac failure	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Cardiopulmonary failure	Cardiac disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Intracardiac thrombus	Cardiac disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Sick sinus syndrome	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Tachycardia	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Ventricular extrasystoles	Cardiac disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Cardiomyopathy	Cardiac disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Sinus tachycardia	Cardiac disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Auricular perichondritis	Ear and labyrinth disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Vertigo	Ear and labyrinth disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Adrenal insufficiency	Endocrine disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Hyperthyroidism	Endocrine disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Ocular icterus	Eye disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Vomiting	Gastrointestinal disorders	EG00016 affected446 at risk EG00125 affected436 at risk
Diarrhoea	Gastrointestinal disorders	EG00015 affected446 at risk EG00115 affected436 at risk
Nausea	Gastrointestinal disorders	EG00011 affected446 at risk EG00113 affected436 at risk
Abdominal pain	Gastrointestinal disorders	EG0009 affected446 at risk EG0016 affected436 at risk
Ascites	Gastrointestinal disorders	EG0009 affected446 at risk EG0013 affected436 at risk
Dysphagia	Gastrointestinal disorders	EG0006 affected446 at risk EG0013 affected436 at risk
Ileus	Gastrointestinal disorders	EG0004 affected446 at risk EG0017 affected436 at risk
Abdominal pain upper	Gastrointestinal disorders	EG0003 affected446 at risk EG0012 affected436 at risk
Intestinal obstruction	Gastrointestinal disorders	EG0003 affected446 at risk EG0013 affected436 at risk
Obstruction gastric	Gastrointestinal disorders	EG0003 affected446 at risk EG0012 affected436 at risk
Subileus	Gastrointestinal disorders	EG0003 affected446 at risk EG0011 affected436 at risk
Melaena	Gastrointestinal disorders	EG0002 affected446 at risk EG0011 affected436 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	EG0002 affected446 at risk EG0012 affected436 at risk
Abdominal distension	Gastrointestinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Abdominal pain lower	Gastrointestinal disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Constipation	Gastrointestinal disorders	EG0001 affected446 at risk EG0015 affected436 at risk
Gastric perforation	Gastrointestinal disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Gastric stenosis	Gastrointestinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Intestinal perforation	Gastrointestinal disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Oesophageal perforation	Gastrointestinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Colonic polyp	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Erosive oesophagitis	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Gastric haemorrhage	Gastrointestinal disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Gastrointestinal stenosis	Gastrointestinal disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Haematemesis	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Haemorrhoids	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Ileus paralytic	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Inguinal hernia	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Mechanical ileus	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Small intestinal obstruction	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Stomatitis	Gastrointestinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
General physical health deterioration	General disorders	EG00012 affected446 at risk EG00113 affected436 at risk
Fatigue	General disorders	EG00011 affected446 at risk EG0015 affected436 at risk
Pyrexia	General disorders	EG0008 affected446 at risk EG0017 affected436 at risk
Disease progression	General disorders	EG0007 affected446 at risk EG0011 affected436 at risk
Asthenia	General disorders	EG0006 affected446 at risk EG0015 affected436 at risk
Mucosal inflammation	General disorders	EG0003 affected446 at risk EG0013 affected436 at risk
Performance status decreased	General disorders	EG0003 affected446 at risk EG0013 affected436 at risk
Device dislocation	General disorders	EG0002 affected446 at risk EG0012 affected436 at risk
Non-cardiac chest pain	General disorders	EG0002 affected446 at risk EG0010 affected436 at risk
Oedema peripheral	General disorders	EG0002 affected446 at risk EG0010 affected436 at risk
Device occlusion	General disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Stent malfunction	General disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Sudden death	General disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Chest discomfort	General disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Death	General disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Multi-organ failure	General disorders	EG0000 affected446 at risk EG0014 affected436 at risk
Pain	General disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Jaundice cholestatic	Hepatobiliary disorders	EG0003 affected446 at risk EG0011 affected436 at risk
Bile duct stenosis	Hepatobiliary disorders	EG0002 affected446 at risk EG0010 affected436 at risk
Cholecystitis	Hepatobiliary disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Cytolytic hepatitis	Hepatobiliary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Hepatic failure	Hepatobiliary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Hepatotoxicity	Hepatobiliary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Jaundice	Hepatobiliary disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Hepatic lesion	Hepatobiliary disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Hypersensitivity	Immune system disorders	EG0004 affected446 at risk EG0010 affected436 at risk
Anaphylactic shock	Immune system disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Sepsis	Infections and infestations	EG0005 affected446 at risk EG0012 affected436 at risk
Pneumonia	Infections and infestations	EG0004 affected446 at risk EG0018 affected436 at risk
Device related infection	Infections and infestations	EG0003 affected446 at risk EG0014 affected436 at risk
Gastroenteritis	Infections and infestations	EG0003 affected446 at risk EG0010 affected436 at risk
Septic shock	Infections and infestations	EG0003 affected446 at risk EG0010 affected436 at risk
Paronychia	Infections and infestations	EG0002 affected446 at risk EG0010 affected436 at risk
Abdominal abscess	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Bacteraemia	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Bronchopulmonary aspergillosis	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Candida sepsis	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Cellulitis	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Enterocolitis bacterial	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Enterocolitis infectious	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Herpes zoster	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Infection	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Klebsiella sepsis	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Liver abscess	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Pneumonia bacterial	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Respiratory tract infection	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Skin infection	Infections and infestations	EG0001 affected446 at risk EG0010 affected436 at risk
Upper respiratory tract infection	Infections and infestations	EG0001 affected446 at risk EG0011 affected436 at risk
Bronchitis	Infections and infestations	EG0000 affected446 at risk EG0011 affected436 at risk
Cystitis	Infections and infestations	EG0000 affected446 at risk EG0011 affected436 at risk
Gangrene	Infections and infestations	EG0000 affected446 at risk EG0011 affected436 at risk
Influenza	Infections and infestations	EG0000 affected446 at risk EG0011 affected436 at risk
Oesophageal candidiasis	Infections and infestations	EG0000 affected446 at risk EG0011 affected436 at risk
Infusion related reaction	Injury, poisoning and procedural complications	EG0002 affected446 at risk EG0010 affected436 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	EG0001 affected446 at risk EG0010 affected436 at risk
Femur fracture	Injury, poisoning and procedural complications	EG0001 affected446 at risk EG0010 affected436 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	EG0001 affected446 at risk EG0010 affected436 at risk
Upper limb fracture	Injury, poisoning and procedural complications	EG0001 affected446 at risk EG0010 affected436 at risk
Concussion	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0011 affected436 at risk
Fall	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0011 affected436 at risk
Laceration	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0011 affected436 at risk
Overdose	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0012 affected436 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0011 affected436 at risk
Post procedural discharge	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0011 affected436 at risk
Road traffic accident	Injury, poisoning and procedural complications	EG0000 affected446 at risk EG0011 affected436 at risk
Blood bilirubin increased	Investigations	EG0002 affected446 at risk EG0010 affected436 at risk
Electrocardiogram QT prolonged	Investigations	EG0002 affected446 at risk EG0010 affected436 at risk
Weight decreased	Investigations	EG0002 affected446 at risk EG0011 affected436 at risk
Alanine aminotransferase increased	Investigations	EG0001 affected446 at risk EG0011 affected436 at risk
Blood creatinine increased	Investigations	EG0001 affected446 at risk EG0015 affected436 at risk
Blood urine	Investigations	EG0001 affected446 at risk EG0010 affected436 at risk
Electrocardiogram low voltage	Investigations	EG0001 affected446 at risk EG0010 affected436 at risk
Glomerular filtration rate decreased	Investigations	EG0001 affected446 at risk EG0010 affected436 at risk
International normalised ratio increased	Investigations	EG0001 affected446 at risk EG0010 affected436 at risk
Liver function test abnormal	Investigations	EG0001 affected446 at risk EG0010 affected436 at risk
Troponin increased	Investigations	EG0001 affected446 at risk EG0010 affected436 at risk
Aspartate aminotransferase increased	Investigations	EG0000 affected446 at risk EG0011 affected436 at risk
Platelet count decreased	Investigations	EG0000 affected446 at risk EG0011 affected436 at risk
Prothrombin time prolonged	Investigations	EG0000 affected446 at risk EG0011 affected436 at risk
Troponin I increased	Investigations	EG0000 affected446 at risk EG0012 affected436 at risk
Decreased appetite	Metabolism and nutrition disorders	EG00015 affected446 at risk EG0013 affected436 at risk
Dehydration	Metabolism and nutrition disorders	EG0009 affected446 at risk EG00115 affected436 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0007 affected446 at risk EG0019 affected436 at risk
Hypophagia	Metabolism and nutrition disorders	EG0003 affected446 at risk EG0011 affected436 at risk
Cachexia	Metabolism and nutrition disorders	EG0002 affected446 at risk EG0010 affected436 at risk
Hypocalcaemia	Metabolism and nutrition disorders	EG0002 affected446 at risk EG0012 affected436 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG0002 affected446 at risk EG0011 affected436 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0002 affected446 at risk EG0013 affected436 at risk
Diabetes mellitus	Metabolism and nutrition disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Malnutrition	Metabolism and nutrition disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0000 affected446 at risk EG0014 affected436 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Bone pain	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0003 affected446 at risk EG0011 affected436 at risk
Metastases to ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected446 at risk EG0010 affected436 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected446 at risk EG0010 affected436 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected446 at risk EG0012 affected436 at risk
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected446 at risk EG0011 affected436 at risk
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected446 at risk EG0010 affected436 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected446 at risk EG0011 affected436 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected446 at risk EG0011 affected436 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected446 at risk EG0011 affected436 at risk
Syncope	Nervous system disorders	EG0006 affected446 at risk EG0014 affected436 at risk
Cerebral infarction	Nervous system disorders	EG0005 affected446 at risk EG0011 affected436 at risk
Ischaemic stroke	Nervous system disorders	EG0003 affected446 at risk EG0011 affected436 at risk
Brain stem infarction	Nervous system disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Cerebral haemorrhage	Nervous system disorders	EG0001 affected446 at risk EG0012 affected436 at risk
Cerebral ischaemia	Nervous system disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Dizziness	Nervous system disorders	EG0001 affected446 at risk EG0015 affected436 at risk
Headache	Nervous system disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Hepatic encephalopathy	Nervous system disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Lumbar radiculopathy	Nervous system disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Spinal cord compression	Nervous system disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Cerebrovascular accident	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Convulsion	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Depressed level of consciousness	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Facial paresis	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Hemiparesis	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Paraesthesia	Nervous system disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Presyncope	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Subarachnoid haemorrhage	Nervous system disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Delirium	Psychiatric disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Depression	Psychiatric disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Completed suicide	Psychiatric disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Renal failure	Renal and urinary disorders	EG0003 affected446 at risk EG0014 affected436 at risk
Renal failure acute	Renal and urinary disorders	EG0002 affected446 at risk EG0010 affected436 at risk
Acute prerenal failure	Renal and urinary disorders	EG0001 affected446 at risk EG0012 affected436 at risk
Calculus ureteric	Renal and urinary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Haematuria	Renal and urinary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Hydronephrosis	Renal and urinary disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Renal colic	Renal and urinary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Renal impairment	Renal and urinary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Ureteric obstruction	Renal and urinary disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Urinary retention	Renal and urinary disorders	EG0001 affected446 at risk EG0011 affected436 at risk
Oliguria	Renal and urinary disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Urinary tract obstruction	Renal and urinary disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG00026 affected446 at risk EG00113 affected436 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0007 affected446 at risk EG0014 affected436 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0004 affected446 at risk EG0011 affected436 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Dermatitis	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Dry skin	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Rash	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Rash generalised	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Skin disorder	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	EG0001 affected446 at risk EG0010 affected436 at risk
Deep vein thrombosis	Vascular disorders	EG00011 affected446 at risk EG0012 affected436 at risk
Hypotension	Vascular disorders	EG0002 affected446 at risk EG0012 affected436 at risk
Peripheral ischaemia	Vascular disorders	EG0002 affected446 at risk EG0010 affected436 at risk
Circulatory collapse	Vascular disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Subclavian vein thrombosis	Vascular disorders	EG0000 affected446 at risk EG0012 affected436 at risk
Venous thrombosis	Vascular disorders	EG0000 affected446 at risk EG0011 affected436 at risk
Venous thrombosis limb	Vascular disorders	EG0000 affected446 at risk EG0011 affected436 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Neutropenia	Blood and lymphatic system disorders	EG000194 affected446 at risk EG001234 affected436 at risk
Anaemia	Blood and lymphatic system disorders	EG000127 affected446 at risk EG001155 affected436 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG00081 affected446 at risk EG00189 affected436 at risk
Leukopenia	Blood and lymphatic system disorders	EG00067 affected446 at risk EG00194 affected436 at risk
Tinnitus	Ear and labyrinth disorders	EG00020 affected446 at risk EG00123 affected436 at risk
Nausea	Gastrointestinal disorders	EG000273 affected446 at risk EG001265 affected436 at risk
Diarrhoea	Gastrointestinal disorders	EG000172 affected446 at risk EG001105 affected436 at risk
Vomiting	Gastrointestinal disorders	EG000165 affected446 at risk EG001192 affected436 at risk
Constipation	Gastrointestinal disorders	EG000120 affected446 at risk EG001110 affected436 at risk
Stomatitis	Gastrointestinal disorders	EG000100 affected446 at risk EG00141 affected436 at risk
Abdominal pain	Gastrointestinal disorders	EG00092 affected446 at risk EG00172 affected436 at risk
Abdominal pain upper	Gastrointestinal disorders	EG00067 affected446 at risk EG00144 affected436 at risk
Dyspepsia	Gastrointestinal disorders	EG00045 affected446 at risk EG00121 affected436 at risk
Dysphagia	Gastrointestinal disorders	EG00023 affected446 at risk EG00114 affected436 at risk
Fatigue	General disorders	EG000187 affected446 at risk EG001162 affected436 at risk
Asthenia	General disorders	EG00092 affected446 at risk EG00198 affected436 at risk
Mucosal inflammation	General disorders	EG00065 affected446 at risk EG00131 affected436 at risk
Pyrexia	General disorders	EG00064 affected446 at risk EG00138 affected436 at risk
Oedema peripheral	General disorders	EG00027 affected446 at risk EG00126 affected436 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	EG00025 affected446 at risk EG00111 affected436 at risk
Paronychia	Infections and infestations	EG00063 affected446 at risk EG0013 affected436 at risk
Weight decreased	Investigations	EG000107 affected446 at risk EG00177 affected436 at risk
Haemoglobin decreased	Investigations	EG00037 affected446 at risk EG00137 affected436 at risk
Glomerular filtration rate decreased	Investigations	EG00030 affected446 at risk EG00135 affected436 at risk
Blood creatinine increased	Investigations	EG00029 affected446 at risk EG00137 affected436 at risk
Aspartate aminotransferase increased	Investigations	EG00026 affected446 at risk EG00113 affected436 at risk
Alanine aminotransferase increased	Investigations	EG00024 affected446 at risk EG00116 affected436 at risk
Neutrophil count decreased	Investigations	EG00020 affected446 at risk EG00122 affected436 at risk
Platelet count decreased	Investigations	EG00017 affected446 at risk EG00122 affected436 at risk
Decreased appetite	Metabolism and nutrition disorders	EG000221 affected446 at risk EG001201 affected436 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG000133 affected446 at risk EG00160 affected436 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG00086 affected446 at risk EG00156 affected436 at risk
Hypocalcaemia	Metabolism and nutrition disorders	EG00067 affected446 at risk EG00138 affected436 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG00042 affected446 at risk EG00134 affected436 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	EG00039 affected446 at risk EG00124 affected436 at risk
Dehydration	Metabolism and nutrition disorders	EG00029 affected446 at risk EG00114 affected436 at risk
Hypophosphataemia	Metabolism and nutrition disorders	EG00029 affected446 at risk EG00113 affected436 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG00035 affected446 at risk EG00119 affected436 at risk
Dizziness	Nervous system disorders	EG00066 affected446 at risk EG00145 affected436 at risk
Peripheral sensory neuropathy	Nervous system disorders	EG00033 affected446 at risk EG00127 affected436 at risk
Dysgeusia	Nervous system disorders	EG00032 affected446 at risk EG00129 affected436 at risk
Headache	Nervous system disorders	EG00031 affected446 at risk EG00122 affected436 at risk
Neuropathy peripheral	Nervous system disorders	EG00023 affected446 at risk EG00141 affected436 at risk
Paraesthesia	Nervous system disorders	EG00020 affected446 at risk EG00127 affected436 at risk
Insomnia	Psychiatric disorders	EG00041 affected446 at risk EG00132 affected436 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00038 affected446 at risk EG00119 affected436 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00037 affected446 at risk EG00121 affected436 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	EG00029 affected446 at risk EG00147 affected436 at risk
Rash	Skin and subcutaneous tissue disorders	EG000194 affected446 at risk EG00123 affected436 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	EG000162 affected446 at risk EG00197 affected436 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	EG00078 affected446 at risk EG0010 affected436 at risk
Dry skin	Skin and subcutaneous tissue disorders	EG00056 affected446 at risk EG00111 affected436 at risk
Acne	Skin and subcutaneous tissue disorders	EG00054 affected446 at risk EG0011 affected436 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG00028 affected446 at risk EG00119 affected436 at risk
Skin fissures	Skin and subcutaneous tissue disorders	EG00028 affected446 at risk EG0011 affected436 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	EG00015 affected446 at risk EG00127 affected436 at risk

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description
BG000	Cetuximab Plus Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
BG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
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 Capecitabine Plus Cisplatin	Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.			239	446	441	446
EG001	Capecitabine Plus Cisplatin	Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.			194	436	429	436