Second Line ColoRectal Cancer Therapy in Combination With... | NCT00278889

Label	Type	Description	Intervention Names
1	Active Comparator	Bevacizumab + FOLFOX	Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Bevacizumab
2	Experimental	AZD2171 + FOLFOX	Drug: AZD2171 Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
AZD2171	Drug	oral tablet	2	cediranib RECENTIN™

Measure	Description	Time Frame
Progression Free Survival	Number of months from randomisation to the earlier date of objective progression or death	Randomisation to data cut-off date of November 2007

Measure	Description	Time Frame
Objective Response Rate	Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.	Randomisation to data cut-off date of November 2007

Name	Affiliation	Role
Jane Robertson	AstraZeneca	Study Director

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

ID	Title	Description
FG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
FG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg

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

Number of months from randomisation to the earlier date of objective progression or death

Posted

Median

Inter-Quartile Range

Months

Randomisation to data cut-off date of November 2007

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG00071 OG00173 OG00266

Title

Denominators

Categories

Title	Measurements
	OG0005.8(3.9 to 8.9) OG0017.2(4.6 to 8.8) OG0027.8(5.3 to 10.8)

Secondary

Objective Response Rate

Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.

Posted

Number

Participants

Randomisation to data cut-off date of November 2007

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG000

Secondary

Overall Survival

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

Posted

Median

Inter-Quartile Range

Months

Randomisation to data cut-off date of 30 January 2009

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG000

Secondary

Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)

Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires

Posted

Median

Inter-Quartile Range

Days

Randomisation to data cut-off date of November 2007

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG000

Secondary

QOL: Time to Worsening of Treatment-free Survival (TFS)

Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires

Posted

Median

Inter-Quartile Range

Days

Randomisation to data cut-off date of November 2007

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG000

Secondary

QOL: Time to Worsening of Clear Cell Sarcoma (CCS)

Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Posted

Median

Inter-Quartile Range

Days

Randomisation to data cut-off date of November 2007

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG000

Secondary

QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)

Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Posted

Median

Inter-Quartile Range

Days

Randomisation to data cut-off date of November 2007

ID	Title	Description
OG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
OG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
OG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Blindness	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0010 affected73 at risk EG0023 affected66 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0013 affected73 at risk EG0023 affected66 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0022 affected66 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0012 affected73 at risk EG0020 affected66 at risk
Abdominal Symptom	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Colitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Colonic Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Gastrointestinal Toxicity	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Ileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0011 affected73 at risk EG0021 affected66 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Small Intestinal Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Subileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0011 affected73 at risk EG0021 affected66 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0013 affected73 at risk EG0020 affected66 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0012 affected73 at risk EG0022 affected66 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Infusion Site Extravasation	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Malaise	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Sudden Cardiac Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0021 affected66 at risk
Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0022 affected66 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0022 affected66 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Catheter Related Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Central Line Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0021 affected66 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Klebsiella Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Lung Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0021 affected66 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Sepsis Syndrome	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Anastomotic Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Anastomotic Ulcer	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Blood Creatinine Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Weight Decreased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0013 affected73 at risk EG0021 affected66 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0012 affected73 at risk EG0021 affected66 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Somnolence	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Confusional State	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0012 affected73 at risk EG0020 affected66 at risk
Agitation	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0010 affected73 at risk EG0020 affected66 at risk
Renal Failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Ureteric Obstruction	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG00037 affected70 at risk EG00132 affected73 at risk EG00229 affected66 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG00026 affected70 at risk EG00129 affected73 at risk EG00215 affected66 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected70 at risk EG0018 affected73 at risk EG0025 affected66 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected70 at risk EG0017 affected73 at risk EG0025 affected66 at risk
Hypothyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0015 affected73 at risk EG0021 affected66 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00052 affected70 at risk EG00154 affected73 at risk EG00242 affected66 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00035 affected70 at risk EG00141 affected73 at risk EG00238 affected66 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00022 affected70 at risk EG00133 affected73 at risk EG00225 affected66 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00022 affected70 at risk EG00128 affected73 at risk EG00225 affected66 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00018 affected70 at risk EG00121 affected73 at risk EG00214 affected66 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected70 at risk EG00113 affected73 at risk EG00218 affected66 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected70 at risk EG0016 affected73 at risk EG0025 affected66 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected70 at risk EG0014 affected73 at risk EG0025 affected66 at risk
Aphthous Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0011 affected73 at risk EG0026 affected66 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected70 at risk EG0013 affected73 at risk EG0023 affected66 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0026 affected66 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected70 at risk EG0011 affected73 at risk EG0020 affected66 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected70 at risk EG0015 affected73 at risk EG0021 affected66 at risk
Toothache	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected70 at risk EG0013 affected73 at risk EG0023 affected66 at risk
Paraesthesia Oral	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0014 affected73 at risk EG0023 affected66 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG00035 affected70 at risk EG00141 affected73 at risk EG00239 affected66 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected70 at risk EG00116 affected73 at risk EG0029 affected66 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected70 at risk EG00113 affected73 at risk EG00215 affected66 at risk
Oedema Peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0013 affected73 at risk EG0025 affected66 at risk
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0013 affected73 at risk EG0023 affected66 at risk
Mucosal Inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0011 affected73 at risk EG0024 affected66 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0012 affected73 at risk EG0025 affected66 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0015 affected73 at risk EG0027 affected66 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0007 affected70 at risk EG0017 affected73 at risk EG0025 affected66 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected70 at risk EG0014 affected73 at risk EG0025 affected66 at risk
Weight Decreased	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00017 affected70 at risk EG0017 affected73 at risk EG0028 affected66 at risk
Aspartate Aminotransferase Increased	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected70 at risk EG0014 affected73 at risk EG0021 affected66 at risk
Alanine Aminotransferase Increased	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0014 affected73 at risk EG0020 affected66 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG00029 affected70 at risk EG00124 affected73 at risk EG00229 affected66 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected70 at risk EG0015 affected73 at risk EG0025 affected66 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected70 at risk EG0017 affected73 at risk EG0024 affected66 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0015 affected73 at risk EG0024 affected66 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected70 at risk EG0011 affected73 at risk EG0025 affected66 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected70 at risk EG0016 affected73 at risk EG00213 affected66 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG00110 affected73 at risk EG0028 affected66 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected70 at risk EG0016 affected73 at risk EG0024 affected66 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected70 at risk EG0013 affected73 at risk EG0026 affected66 at risk
Paraesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00020 affected70 at risk EG00131 affected73 at risk EG00224 affected66 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00020 affected70 at risk EG00117 affected73 at risk EG00225 affected66 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected70 at risk EG00116 affected73 at risk EG00216 affected66 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected70 at risk EG0016 affected73 at risk EG00212 affected66 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected70 at risk EG0019 affected73 at risk EG00210 affected66 at risk
Dysaesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0012 affected73 at risk EG0027 affected66 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected70 at risk EG0014 affected73 at risk EG0024 affected66 at risk
Polyneuropathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected70 at risk EG0013 affected73 at risk EG0024 affected66 at risk
Lethargy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected70 at risk EG0017 affected73 at risk EG0025 affected66 at risk
Anxiety	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0014 affected73 at risk EG0024 affected66 at risk
Proteinuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected70 at risk EG00113 affected73 at risk EG00215 affected66 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00022 affected70 at risk EG00121 affected73 at risk EG00213 affected66 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected70 at risk EG00115 affected73 at risk EG00213 affected66 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected70 at risk EG0014 affected73 at risk EG00211 affected66 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected70 at risk EG00110 affected73 at risk EG0026 affected66 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0011 affected73 at risk EG0024 affected66 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected70 at risk EG0014 affected73 at risk EG0023 affected66 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected70 at risk EG0018 affected73 at risk EG0027 affected66 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected70 at risk EG0018 affected73 at risk EG00210 affected66 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected70 at risk EG0011 affected73 at risk EG0028 affected66 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0018 affected73 at risk EG0028 affected66 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0017 affected73 at risk EG0021 affected66 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0014 affected73 at risk EG0022 affected66 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected70 at risk EG0010 affected73 at risk EG0021 affected66 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00035 affected70 at risk EG00143 affected73 at risk EG00232 affected66 at risk
Pallor	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected70 at risk EG0014 affected73 at risk EG0021 affected66 at risk

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

ID	Term
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
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg
BG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg
BG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg
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	FOLFOX + Cediranib 20 mg	FOLFOX + Cediranib 20 mg	30	73	69	73
EG001	FOLFOX + Cediranib 30 mg	FOLFOX + Cediranib 30 mg	39	74	73	74
EG002	FOLFOX + Bevacizumab 10 mg/kg	FOLFOX + Bevacizumab 10 mg/kg	29	68	66	68

ID	Term
C500926	cediranib
D005472	Fluorouracil
D002955	Leucovorin
D000077150	Oxaliplatin
D000068258	Bevacizumab

ID	Type	Description	Link
EUDRACT number 2005-003443-31
HORIZON I