A Study of Avastin (Bevacizumab) in Combination With Xelo... | NCT01135498

Label	Type	Description	Intervention Names
1	Experimental		Drug: bevacizumab [Avastin] Drug: eloxatin Drug: capecitabine [Xeloda] Drug: erlotinib [Tarceva]

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	Intravenous repeating dose	1
eloxatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Disease Progression or Death	Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.	Start of study to approximately 4 years
Progression-Free Survival	Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).	From study start up to approximately 4 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])	Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
		Palma de Mallorca	Balearic Islands	07198	Spain

ID	Title	Description
FG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

ID	Title	Description
BG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Units	Counts
Participants	BG00090

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

Percentage of Participants With Disease Progression or Death

Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.

ITT population

Posted

Number

percentage of participants

Start of study to approximately 4 years

ID	Title	Description
OG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Units	Counts
Participants	OG00090

Title

Denominators

Categories

Title	Measurements
	OG00061.1

Secondary

Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])

Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Response-Evaluable population: all enrolled participants who received at least 3 cycles of treatment, had all baseline lesions evaluated at least once after receiving the third cycle (using same technique as at baseline), and were without major violations of the study protocol.

Posted

Number

percentage of participants

From study start up to approximately 4 years

ID	Title	Description
OG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Secondary

Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])

Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.

Response-Evaluable population

Posted

Number

percentage of participants

From study start up to approximately 4 years

ID	Title	Description
OG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Units

Secondary

Percentage of Participants Who Died

ITT population

Posted

Number

percentage of participants

From study start up to approximately 4 years

ID	Title	Description
OG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Units	Counts
Participants	OG000

Primary

Progression-Free Survival

Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).

ITT population

Posted

Median

95% Confidence Interval

months

From study start up to approximately 4 years

ID	Title	Description
OG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Units	Counts
Participants

Secondary

Overall Survival (OS)

Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.

ITT population

Posted

Median

95% Confidence Interval

months

From study start up to approximately 4 years

ID	Title	Description
OG000	Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib	Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0007 affected90 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00018 affected90 at risk
Vomiting	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Nausea	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Subileus	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Enteritis	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Asthenia	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG00011 affected90 at risk
General physical health deterioration	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Mucosal inflammation	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Adverse drug reaction	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pyrexia	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Respiratory tract infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Perirectal abscess	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Folliculitis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pneumonia	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Urinary tract infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Gastroenteritis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Gamma-glutamyltransferase	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Blood potassium decreased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Dysaesthesia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Headache	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Anxiety	Psychiatric disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Confusional state	Psychiatric disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0006 affected90 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Palmar-plantar erythrodysaesthesia	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hypertension	Vascular disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00025 affected90 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00018 affected90 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00013 affected90 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00012 affected90 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Tachycardia	Cardiac disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Conjunctivitis	Eye disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Lacrimation increased	Eye disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Xerophthalmia	Eye disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Ocular icterus	Eye disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Scotoma	Eye disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00056 affected90 at risk
Nausea	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00041 affected90 at risk
Vomiting	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00036 affected90 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00031 affected90 at risk
Constipation	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00016 affected90 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00012 affected90 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0009 affected90 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0009 affected90 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0006 affected90 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Subileus	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Flatulence	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Enteritis	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Gastrointestinal mucositis	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Toothache	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Aerophagia	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Atrophy of tongue papillae	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Anal discomfort	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Asthenia	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG00069 affected90 at risk
Pyrexia	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG00021 affected90 at risk
Mucosal inflammation	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG00018 affected90 at risk
Pain	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Oedema	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Oedema peripheral	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
General physical health deterioration	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Face oedema	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Mucosal dryness	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hernia	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Adverse drug reaction	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Infusion site pain	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Temperature intolerance	General disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Jaundice	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Hypersensitivity	Immune system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Respiratory tract infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Cellulitis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Folliculitis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Oral infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Nasopharyngitis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Urinary tract infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Paronychia	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Perirectal abscess	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Abscess limb	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Nail infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Ear infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Skin infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pneumonia	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Influenza	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pharyngitis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Furuncle	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Gastroenteritis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Weight decreased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0005 affected90 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Gamma-glutamyltransferase	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Alanine aminotransferase increased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Blood lactate dehydrogenase	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Blood potassium decreased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Weight increased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Platelet count decreased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Alanine aminotransferase	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Blood glucose abnormal	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Blood bilirubin increased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG00035 affected90 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0008 affected90 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0008 affected90 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0006 affected90 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Paraesthesia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00035 affected90 at risk
Neurotoxicity	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00032 affected90 at risk
Dysaesthesia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG00024 affected90 at risk
Dysgeusia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0008 affected90 at risk
Headache	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0007 affected90 at risk
Neuropathy	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Aphonia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Tremor	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Dizziness	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Ageusia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Parosmia	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Somnolence	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Insomnia	Psychiatric disorders	MedDRA (8.1)	Non-systematic Assessment	EG0006 affected90 at risk
Anxiety	Psychiatric disorders	MedDRA (8.1)	Non-systematic Assessment	EG0005 affected90 at risk
Depression	Psychiatric disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Confusional state	Psychiatric disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Proteinuria	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0009 affected90 at risk
Dysuria	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Renal colic	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Renal failure	Renal and urinary disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG00014 affected90 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0005 affected90 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG00038 affected90 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG00029 affected90 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0008 affected90 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0005 affected90 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0005 affected90 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected90 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0002 affected90 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Plantar erythema	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Acanthosis	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hypertension	Vascular disorders	MedDRA (8.1)	Non-systematic Assessment	EG00015 affected90 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected90 at risk
Hypertensive crisis	Vascular disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk
Hypotension	Vascular disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected90 at risk

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D056831	Coordination Complexes
D009930	Organic Chemicals
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
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D000068258	Bevacizumab
D000077150	Oxaliplatin
D000069287	Capecitabine
D000069347	Erlotinib Hydrochloride