Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherap... | NCT00399035

Label	Type	Description	Intervention Names
FOLFOX + placebo Cediranib	Placebo Comparator	FOLFOX + placebo Cediranib	Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) Drug: Cediranib Placebo
Xelox + placebo Cediranib	Placebo Comparator	Xelox + placebo Cediranib	Drug: XELOX (Capecitabine and Oxaliplatin) Drug: Cediranib Placebo
FOLFOX + Cediranib	Experimental	FOLFOX + Cediranib	Drug: Cediranib Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
XELOX + Cediranib	Experimental	XELOX + Cediranib	Drug: Cediranib Drug: XELOX (Capecitabine and Oxaliplatin)

Name	Type	Description	Arm Group Labels	Other Names
Cediranib	Drug	oral tablet	FOLFOX + Cediranib XELOX + Cediranib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival	RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.	RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
Overall Survival	Number of months from randomisation to the date of death from any cause	Baseline through to date of death upto and including data cut off date of 21/03/10

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate	Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi

Name	Affiliation	Role
Jane Robertson	AstraZeneca	Study Director

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

PubMed Identifier	Type	Citation	Retractions
23510802	Derived	Smith JC, Brooks L, Hoff PM, McWalter G, Dearden S, Morgan SR, Wilson D, Robertson JD, Jurgensmeier JM. KRAS mutations are associated with inferior clinical outcome in patients with metastatic colorectal cancer, but are not predictive for benefit with cediranib. Eur J Cancer. 2013 Jul;49(10):2424-32. doi: 10.1016/j.ejca.2013.02.023. Epub 2013 Mar 16.

Label	URL
CSR-D8480C00051.pdf	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cediranib 20 mg/Day	[Cediranib 20mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.

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

RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Median

Inter-Quartile Range

Months

RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo	Placebo + FOLFOX/XELOX

Units	Counts
Participants	OG000502 OG001358

Title

Denominators

Categories

Title	Measurements
	OG0008.6(5.5 to 12.1) OG0018.2(4.1 to 11.1)

Primary

Overall Survival

Number of months from randomisation to the date of death from any cause

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Median

Inter-Quartile Range

Months

Baseline through to date of death upto and including data cut off date of 21/03/10

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo	Placebo + FOLFOX/XELOX

Units	Counts
Participants	OG000

Secondary

Overall Response Rate

Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Number

Participants

Baseline through to date of death upto and including data cut off date of 21/03/10

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo

Secondary

Best Percentage Change in Tumour Size

Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Mean

Standard Deviation

Percentage [change in tumour size (mm) ]

Baseline through to date of death upto and including data cut off date of 21/03/10

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo	Placebo + FOLFOX/XELOX

Units	Counts
Participants	OG000

Secondary

Duration of Response

Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Median

Inter-Quartile Range

Months

Treatment period from initial response up until data cut-off date of 21/03/10

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo	Placebo + FOLFOX/XELOX

Units	Counts
Participants	OG000

Secondary

Rate of Resection of Liver Metastases

Number of patients undergoing liver resection, based on patients with liver disease at baseline

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Number

Participants

Post-randomisation until end of study

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo	Placebo + FOLFOX/XELOX

Units	Counts
Participants	OG000

Secondary

Time to Wound Healing Complications

Number of days from post-randomisation surgery until wound healing complications

Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.

Posted

Median

Full Range

Days

Post-randomisation until end of study

ID	Title	Description
OG000	Cediranib 20 mg	Cediranib 20 mg/day + FOLFOX/XELOX
OG001	Placebo	Placebo + FOLFOX/XELOX

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG00111 affected500 at risk EG0027 affected358 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0017 affected500 at risk EG0023 affected358 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected214 at risk EG0014 affected500 at risk EG0023 affected358 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0013 affected500 at risk EG0022 affected358 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0022 affected358 at risk
Coombs Positive Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0012 affected500 at risk EG0023 affected358 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Cardiac Failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0021 affected358 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Angina Pectoris	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Bradycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Ventricular Dysfunction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Hypothyroidism	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Thyroiditis	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Retinal Haemorrhage	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Retinal Vein Occlusion	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected214 at risk EG00134 affected500 at risk EG00211 affected358 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0018 affected500 at risk EG0024 affected358 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected214 at risk EG0017 affected500 at risk EG0028 affected358 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0015 affected500 at risk EG0024 affected358 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0014 affected500 at risk EG0021 affected358 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0014 affected500 at risk EG0022 affected358 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0013 affected500 at risk EG0023 affected358 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0012 affected500 at risk EG0021 affected358 at risk
Subileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0012 affected500 at risk EG0022 affected358 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0020 affected358 at risk
Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0022 affected358 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0021 affected358 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Anal Haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Ascites	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Colitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Colonic Obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Duodenal Ulcer Perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Gastrointestinal Fistula	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Gastrointestinal Necrosis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Gastrointestinal Perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Ileitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Intestinal Fistula	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Mechanical Ileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Melaena	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Mesenteric Vein Thrombosis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Proctocolitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Rectal Obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Varices Oesophageal	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0015 affected500 at risk EG0024 affected358 at risk
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0023 affected358 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0013 affected500 at risk EG0020 affected358 at risk
Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
General Physical Health Deterioration	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Infusion Site Irritation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Multi-Organ Failure	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Performance Status Decreased	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Sudden Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0023 affected358 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0020 affected358 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0020 affected358 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Hepatorenal Failure	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Jaundice	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0023 affected358 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0013 affected500 at risk EG0022 affected358 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0012 affected500 at risk EG0020 affected358 at risk
Food Allergy	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0017 affected500 at risk EG0028 affected358 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0016 affected500 at risk EG0022 affected358 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG0014 affected500 at risk EG0023 affected358 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0013 affected500 at risk EG0020 affected358 at risk
Septic Shock	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0013 affected500 at risk EG0021 affected358 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0021 affected358 at risk
Abdominal Wall Abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Acute Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Amoebiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Amoebic Dysentery	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Appendicitis Perforated	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Blastocystis Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Bronchopneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Campylobacter Intestinal Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Catheter Related Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Catheter Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Catheter Site Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Central Line Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Colostomy Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Dengue Fever	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Infected Epidermal Cyst	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Lung Abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Meningitis Bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Oral Candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Pyelonephritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pyothorax	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Scrotal Abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Wound Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0012 affected500 at risk EG0024 affected358 at risk
Comminuted Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Gastrointestinal Stoma Complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Peroneal Nerve Injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Postoperative Hernia	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Stent Occlusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Ureteric Injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Wound Complication	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Bilirubin Conjugated Increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
International Normalised Ratio Increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Liver Function Test Abnormal	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Platelet Count Decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected214 at risk EG00114 affected500 at risk EG0027 affected358 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0013 affected500 at risk EG0021 affected358 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0022 affected358 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0012 affected500 at risk EG0020 affected358 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Benign Neoplasm Of Spinal Cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Penis Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0014 affected500 at risk EG0020 affected358 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0013 affected500 at risk EG0020 affected358 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0022 affected358 at risk
Aphasia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Central Nervous System Lesion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Dysarthria	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Encephalopathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Hemiparesis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Metabolic Encephalopathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Monoparesis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Nervous System Disorder	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Neuralgia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Neurological Symptom	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Reversible Posterior Leukoencephalopathy Syndrome	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Syncope	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Confusional State	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Personality Change Due To A General Medical Condition	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Renal Failure	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected214 at risk EG0013 affected500 at risk EG0020 affected358 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0013 affected500 at risk EG0020 affected358 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0013 affected500 at risk EG0021 affected358 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0012 affected500 at risk EG0021 affected358 at risk
Azotaemia	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0021 affected358 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Ureteric Obstruction	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Urinary Bladder Haemorrhage	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0013 affected500 at risk EG0020 affected358 at risk
Female Genital Tract Fistula	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected214 at risk EG00110 affected500 at risk EG0024 affected358 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0014 affected500 at risk EG0021 affected358 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0022 affected358 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Dysaesthesia Pharynx	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Pulmonary Artery Thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0008 affected214 at risk EG0016 affected500 at risk EG0022 affected358 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected214 at risk EG0013 affected500 at risk EG0021 affected358 at risk
Aortic Thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0021 affected358 at risk
Peripheral Embolism	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Phlebitis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk
Thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected214 at risk EG0010 affected500 at risk EG0020 affected358 at risk
Vena Cava Thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected214 at risk EG0011 affected500 at risk EG0020 affected358 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00056 affected214 at risk EG001139 affected500 at risk EG00284 affected358 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00049 affected214 at risk EG001138 affected500 at risk EG00275 affected358 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00015 affected214 at risk EG00184 affected500 at risk EG00239 affected358 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG00024 affected214 at risk EG00140 affected500 at risk EG00243 affected358 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected214 at risk EG00128 affected500 at risk EG0029 affected358 at risk
Hypothyroidism	Endocrine disorders	MedDRA 12.1	Systematic Assessment	EG00028 affected214 at risk EG00142 affected500 at risk EG0028 affected358 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG000147 affected214 at risk EG001346 affected500 at risk EG002165 affected358 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00092 affected214 at risk EG001256 affected500 at risk EG002169 affected358 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00083 affected214 at risk EG001230 affected500 at risk EG002126 affected358 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00032 affected214 at risk EG001134 affected500 at risk EG00278 affected358 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00059 affected214 at risk EG001118 affected500 at risk EG00248 affected358 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00034 affected214 at risk EG00185 affected500 at risk EG00278 affected358 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00024 affected214 at risk EG00158 affected500 at risk EG00228 affected358 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG00018 affected214 at risk EG00135 affected500 at risk EG00220 affected358 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected214 at risk EG00127 affected500 at risk EG00219 affected358 at risk
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected214 at risk EG00127 affected500 at risk EG00212 affected358 at risk
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG00080 affected214 at risk EG001200 affected500 at risk EG002104 affected358 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG00031 affected214 at risk EG00176 affected500 at risk EG00260 affected358 at risk
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG00032 affected214 at risk EG00174 affected500 at risk EG00245 affected358 at risk
Oedema Peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG00022 affected214 at risk EG00153 affected500 at risk EG00246 affected358 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected214 at risk EG00124 affected500 at risk EG00219 affected358 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00015 affected214 at risk EG00140 affected500 at risk EG00214 affected358 at risk
Weight Decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG00028 affected214 at risk EG00163 affected500 at risk EG00218 affected358 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 12.1	Systematic Assessment	EG00011 affected214 at risk EG00133 affected500 at risk EG00215 affected358 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0009 affected214 at risk EG00133 affected500 at risk EG00218 affected358 at risk
Platelet Count Decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0006 affected214 at risk EG00133 affected500 at risk EG00217 affected358 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00092 affected214 at risk EG001229 affected500 at risk EG002125 affected358 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG00019 affected214 at risk EG00158 affected500 at risk EG00222 affected358 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected214 at risk EG00148 affected500 at risk EG00214 affected358 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00017 affected214 at risk EG00141 affected500 at risk EG00219 affected358 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00015 affected214 at risk EG00134 affected500 at risk EG00214 affected358 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected214 at risk EG00122 affected500 at risk EG00212 affected358 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00045 affected214 at risk EG001141 affected500 at risk EG00289 affected358 at risk
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00049 affected214 at risk EG00197 affected500 at risk EG00285 affected358 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00024 affected214 at risk EG00177 affected500 at risk EG00264 affected358 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00035 affected214 at risk EG00170 affected500 at risk EG00234 affected358 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00019 affected214 at risk EG00152 affected500 at risk EG00223 affected358 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected214 at risk EG00138 affected500 at risk EG00217 affected358 at risk
Dysgeusia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected214 at risk EG00126 affected500 at risk EG00225 affected358 at risk
Dysaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected214 at risk EG00116 affected500 at risk EG00211 affected358 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG00015 affected214 at risk EG00150 affected500 at risk EG00227 affected358 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG00020 affected214 at risk EG00160 affected500 at risk EG00212 affected358 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00039 affected214 at risk EG00167 affected500 at risk EG0024 affected358 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00037 affected214 at risk EG00163 affected500 at risk EG00231 affected358 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00024 affected214 at risk EG00150 affected500 at risk EG00235 affected358 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected214 at risk EG00129 affected500 at risk EG00224 affected358 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00012 affected214 at risk EG00128 affected500 at risk EG0026 affected358 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected214 at risk EG00123 affected500 at risk EG0028 affected358 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00053 affected214 at risk EG001123 affected500 at risk EG00257 affected358 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00018 affected214 at risk EG00138 affected500 at risk EG00222 affected358 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0009 affected214 at risk EG00134 affected500 at risk EG00225 affected358 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0009 affected214 at risk EG00133 affected500 at risk EG00219 affected358 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG00014 affected214 at risk EG00116 affected500 at risk EG00211 affected358 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG00096 affected214 at risk EG001226 affected500 at risk EG00241 affected358 at risk
Phlebitis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected214 at risk EG00119 affected500 at risk EG00218 affected358 at risk

ID	Title	Description
BG000	Cediranib 20 mg	Cediranib 20 mg + FOLFOX/XELOX
BG001	Placebo	Placebo + FOLFOX/XELOX
BG002	Cediranib 30 mg	Cediranib 30 mg/day + FOLFOX/XELOX
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cediranib 30mg	Cediranib 30mg/day + Folfox/Xelox	94	214	209	214
EG001	Cediranib 20mg	Cediranib 20mg/day + Folfox/Xelox	204	500	485	500
EG002	Placebo	Placebo + Folfox/Xelox	105	358	341	358

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
C500926	cediranib
C410216	Folfox protocol
D005472	Fluorouracil
D002955	Leucovorin
D000077150	Oxaliplatin
D007262	Infusions, Intravenous
C519688	XELOX
D000069287	Capecitabine

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D056831	Coordination Complexes
D009930	Organic Chemicals
D061605	Administration, Intravenous
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D007263	Infusions, Parenteral
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Type	Description	Link
EUDRACT No 2006-001194-14
HORIZON II