Study Of FOLFIRI Chemotherapy With Or Without Sunitinib I... | NCT00457691

NCT00457691

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: 5 fluorouracil Drug: irinotecan Drug: levo- leucovorin Drug: sunitinib
2	Placebo Comparator		Drug: 5 fluorouracil Drug: irinotecan Drug: levo- leucovorin Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
5 fluorouracil	Drug	400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.	First dose of study treatment up to 30 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.	Baseline up to 30 months
Number of Participants With Overall Confirmed Objective Response

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		La Plata	Buenos Aires	B1902AVQ	Argentina
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23358972	Derived	Carrato A, Swieboda-Sadlej A, Staszewska-Skurczynska M, Lim R, Roman L, Shparyk Y, Bondarenko I, Jonker DJ, Sun Y, De la Cruz JA, Williams JA, Korytowsky B, Christensen JG, Lin X, Tursi JM, Lechuga MJ, Van Cutsem E. Fluorouracil, leucovorin, and irinotecan plus either sunitinib or placebo in metastatic colorectal cancer: a randomized, phase III trial. J Clin Oncol. 2013 Apr 1;31(10):1341-7. doi: 10.1200/JCO.2012.45.1930. Epub 2013 Jan 28.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
BG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00033.6(30.80 to 36.60) OG00136.6(32.90 to 40.00)

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		Log Rank		0.8072	p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment	Hazard Ratio (HR)	1.095			2-Sided	95	0.892	1.344				No	Superiority or Other

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.

ITT Population.

Posted

Median

95% Confidence Interval

Weeks

Baseline up to 30 months

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.

Units

Secondary

Number of Participants With Overall Confirmed Objective Response

Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Posted

Number

Participants

Day 28 of Cycle 1 up to 30 months

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.

Secondary

Duration of Response (DR)

DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.

ITT Population (participants with a confirmed objective tumor response).

Posted

Median

95% Confidence Interval

Weeks

Day 28 of Cycle 1 up to 30 months

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.

Secondary

Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score

Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).

ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, and 11).

Posted

Mean

95% Confidence Interval

Scores on a scale

Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo

Secondary

Change From Baseline in MDASI-GI Symptom Interference Score

Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).

ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, 11).

Posted

Mean

95% Confidence Interval

scores on a scale

Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.

Secondary

Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire

EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state.

ITT population. The EQ-5D health state index results were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).

Posted

Mean

95% Confidence Interval

Scores on a scale

Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo

Secondary

Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)

EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

ITT population. The change from baseline scores for EQ-VAS were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).

Posted

Mean

95% Confidence Interval

Scores on a scale

Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal

ID	Title	Description
OG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
OG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FOLFIRI + Sunitinib	Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.			170	384	382	384
EG001	FOLFIRI + Placebo	IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.			111	379	362	379

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0009 affected384 at risk EG0014 affected379 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00025 affected384 at risk EG00111 affected379 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0009 affected384 at risk EG0013 affected379 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00026 affected384 at risk EG0016 affected379 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected384 at risk EG0011 affected379 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0012 affected379 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0012 affected379 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Cardiac failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0013 affected379 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Pericardial effusion	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Hypothyroidism	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Pupils unequal	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected384 at risk EG0016 affected379 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Ascites	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0012 affected379 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0011 affected379 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00023 affected384 at risk EG00119 affected379 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0012 affected379 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected384 at risk EG0011 affected379 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Gastrooesophagitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0018 affected379 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected384 at risk EG00110 affected379 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected384 at risk EG0014 affected379 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected384 at risk EG0011 affected379 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected384 at risk EG0012 affected379 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0011 affected379 at risk
Subileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected384 at risk EG00111 affected379 at risk
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected384 at risk EG0014 affected379 at risk
Catheter related complication	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Catheter thrombosis	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Chills	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected384 at risk EG0014 affected379 at risk
Disease progression	General disorders	MedDRA 12.1	Systematic Assessment	EG00012 affected384 at risk EG0013 affected379 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected384 at risk EG0011 affected379 at risk
General physical health deterioration	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected384 at risk EG0010 affected379 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG00017 affected384 at risk EG00112 affected379 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Chronic hepatitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Abdominal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Anal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected384 at risk EG0011 affected379 at risk
Bacterial infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Catheter sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Central line infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 affected384 at risk EG0011 affected379 at risk
Cholecystitis infective	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Empyema	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Herpes zoster	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Implant site cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0011 affected379 at risk
Liver abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0011 affected379 at risk
Lung abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Orchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Perirectal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0005 affected384 at risk EG0017 affected379 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Pseudomonas pseudomallei infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0004 affected384 at risk EG0013 affected379 at risk
Septic shock	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Tooth infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0013 affected379 at risk
Urosepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0012 affected379 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Peripancreatic fluid collection	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Stent occlusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Blood creatinine increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0012 affected379 at risk
C-reactive protein increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Cardiac stress test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Renal function test abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected384 at risk EG0014 affected379 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0013 affected379 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0012 affected379 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Leukoerythroblastosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Amnesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Ataxia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0012 affected379 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0011 affected379 at risk
Hemiparesis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Syncope	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Confusional state	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Mental status changes	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Anuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0011 affected379 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected384 at risk EG0013 affected379 at risk
Hydroureter	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0012 affected379 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0012 affected379 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0015 affected379 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected384 at risk EG0018 affected379 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Immobile	Social circumstances	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0011 affected379 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Circulatory collapse	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected384 at risk EG0013 affected379 at risk
Embolism	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected384 at risk EG0010 affected379 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0013 affected379 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected384 at risk EG0012 affected379 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Phlebitis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0010 affected379 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Thrombophlebitis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk
Thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected384 at risk EG0011 affected379 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG000120 affected384 at risk EG00174 affected379 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG000107 affected384 at risk EG00149 affected379 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG000315 affected384 at risk EG001188 affected379 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG000129 affected384 at risk EG00121 affected379 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00021 affected384 at risk EG00126 affected379 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00089 affected384 at risk EG00173 affected379 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00043 affected384 at risk EG00128 affected379 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00089 affected384 at risk EG00172 affected379 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG000247 affected384 at risk EG001182 affected379 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00045 affected384 at risk EG00124 affected379 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG000190 affected384 at risk EG001181 affected379 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00088 affected384 at risk EG00145 affected379 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG000144 affected384 at risk EG001129 affected379 at risk
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG00070 affected384 at risk EG00165 affected379 at risk
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG00028 affected384 at risk EG0019 affected379 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG000120 affected384 at risk EG00193 affected379 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG00087 affected384 at risk EG00166 affected379 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG00027 affected384 at risk EG00126 affected379 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG00067 affected384 at risk EG00153 affected379 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00024 affected384 at risk EG00120 affected379 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG00023 affected384 at risk EG00112 affected379 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Systematic Assessment	EG00022 affected384 at risk EG0019 affected379 at risk
Weight decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG00036 affected384 at risk EG00117 affected379 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG000116 affected384 at risk EG00182 affected379 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00040 affected384 at risk EG00120 affected379 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00037 affected384 at risk EG00132 affected379 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00029 affected384 at risk EG00127 affected379 at risk
Dysgeusia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00030 affected384 at risk EG00120 affected379 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00044 affected384 at risk EG00128 affected379 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG00055 affected384 at risk EG00148 affected379 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00049 affected384 at risk EG00141 affected379 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00029 affected384 at risk EG00115 affected379 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00048 affected384 at risk EG00121 affected379 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG000128 affected384 at risk EG001121 affected379 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00077 affected384 at risk EG00126 affected379 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00041 affected384 at risk EG00132 affected379 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00022 affected384 at risk EG0012 affected379 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00056 affected384 at risk EG00119 affected379 at risk

Ancestor Terms

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

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002166	Camptothecin
D000470	Alkaloids
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D011758	Pyrroles
D001393	Azoles
D007211	Indoles

IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.

ID	Term
D005472	Fluorouracil
D000077146	Irinotecan
D002955	Leucovorin
D000077210	Sunitinib