Sunitinib Plus Prednisone In Patients With Metastatic Cas... | NCT00676650

Label	Type	Description	Intervention Names
A	Experimental	Treatment Arm A - sunitinib + prednisone	Drug: Prednisone Drug: sunitinib
B	Placebo Comparator	Treatment Arm B - placebo + prednisone	Drug: Placebo Drug: Prednisone

Name	Type	Description	Arm Group Labels	Other Names
Prednisone	Drug	5 mg BID, oral	A	Deltasone

Measure	Description	Time Frame
Overall Survival (OS)	OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.	Baseline up to 32 months

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02	Baseline, every 8 weeks up to 123 weeks

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Decatur	Alabama	35601	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
24323035	Derived	Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.

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

ID	Title	Description
FG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.

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

Overall Survival (OS)

OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.

Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.

Posted

Median

95% Confidence Interval

months

Baseline up to 32 months

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Units	Counts
Participants	OG000584 OG001289

Title

Denominators

Categories

Title	Measurements
	OG00013.1(12.0 to 14.1) OG00111.8(10.8 to 14.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.1678	1-sided p-value from the stratified log-rank test	Hazard Ratio (HR)	0.914			2-Sided	95	0.762	1.097			Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.	No	Superiority or Other

Secondary

Progression-Free Survival (PFS)

PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02

FA Population

Posted

Median

95% Confidence Interval

weeks

Baseline, every 8 weeks up to 123 weeks

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Units	Counts

Secondary

Percent of Participants With Objective Response (OR)

OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.

FA Population

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 8 weeks up to 123 weeks

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Secondary

Duration of Response (DR)

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response

Data not summarized, study terminated early

Posted

Baseline, every 8 weeks up to 123 weeks

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Secondary

Change From Baseline in Pain Severity

Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.

Data not summarized, study terminated early

Posted

Day 1 through Day 7 every 28 days (every cycle) up to 29 months

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Units	Counts
Participants

Secondary

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.

Data not summarized, study terminated early

Posted

Baseline, every 4 weeks up to 123 weeks

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Secondary

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.

Data not summarized, study terminated early

Posted

Baseline, every 4 weeks up to 123 weeks

ID	Title	Description
OG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
OG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00021 affected581 at risk EG0013 affected285 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected581 at risk EG0011 affected285 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0011 affected285 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Cerebral arteriovenous malformation haemorrhagic	Congenital, familial and genetic disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Conjunctival oedema	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Diplopia	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0011 affected285 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0013 affected285 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected581 at risk EG0011 affected285 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0007 affected581 at risk EG0011 affected285 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected581 at risk EG0014 affected285 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Proctitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0011 affected285 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Rectal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Rectourethral fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected581 at risk EG0015 affected285 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected581 at risk EG0011 affected285 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0012 affected285 at risk
Death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected581 at risk EG0011 affected285 at risk
Device occlusion	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0011 affected285 at risk
Disease progression	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00032 affected581 at risk EG00119 affected285 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0011 affected285 at risk
General physical health deterioration	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected581 at risk EG0012 affected285 at risk
Ill-defined disorder	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Impaired healing	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Influenza like illness	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Malaise	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Medical device complication	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Multi-organ failure	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0014 affected285 at risk
Performance status decreased	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected581 at risk EG0013 affected285 at risk
Sudden cardiac death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Sudden death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Anal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0006 affected581 at risk EG0010 affected285 at risk
Appendicitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Cholecystitis infective	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Clostridial infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Diverticulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Febrile infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Herpes zoster	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Infectious peritonitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Meningitis bacterial	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Oral fungal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Otitis media chronic	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Paronychia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Perirectal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0014 affected285 at risk
Pseudomonas infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Rectal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Tooth infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00010 affected581 at risk EG0017 affected285 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Urosepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0005 affected581 at risk EG0011 affected285 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Blood creatinine increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Blood urea increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
C-reactive protein increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Prothrombin time prolonged	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Urine output decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected581 at risk EG0012 affected285 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00017 affected581 at risk EG0012 affected285 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0012 affected285 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0011 affected285 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0013 affected285 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected581 at risk EG0015 affected285 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Aphasia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Facial paresis	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hydrocephalus	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Nervous system disorder	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Partial seizures	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Polyneuropathy in malignant disease	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Spinal cord compression	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0013 affected285 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0013 affected285 at risk
Hallucination	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Mental disorder due to a general medical condition	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Azotaemia	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected581 at risk EG0013 affected285 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0012 affected285 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected581 at risk EG0012 affected285 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0010 affected285 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0010 affected285 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected581 at risk EG0013 affected285 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0011 affected285 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected581 at risk EG0010 affected285 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected581 at risk EG0011 affected285 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00019 affected581 at risk EG0013 affected285 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Pain management	Surgical and medical procedures	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Circulatory collapse	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0011 affected285 at risk
Haematoma	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Haemorrhage	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected581 at risk EG0010 affected285 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk
Phlebitis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected581 at risk EG0011 affected285 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected581 at risk EG0010 affected285 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG000140 affected581 at risk EG00153 affected285 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00060 affected581 at risk EG0012 affected285 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00084 affected581 at risk EG0011 affected285 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00072 affected581 at risk EG0018 affected285 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00041 affected581 at risk EG00113 affected285 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00039 affected581 at risk EG00110 affected285 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000112 affected581 at risk EG00156 affected285 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000267 affected581 at risk EG00143 affected285 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00041 affected581 at risk EG00113 affected285 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00099 affected581 at risk EG00111 affected285 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000240 affected581 at risk EG00168 affected285 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00081 affected581 at risk EG00111 affected285 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000189 affected581 at risk EG00139 affected285 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG000153 affected581 at risk EG00141 affected285 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG000202 affected581 at risk EG00169 affected285 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG000118 affected581 at risk EG00114 affected285 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00063 affected581 at risk EG00123 affected285 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00049 affected581 at risk EG00124 affected285 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00057 affected581 at risk EG00112 affected285 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG00051 affected581 at risk EG00112 affected285 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00029 affected581 at risk EG0016 affected285 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00037 affected581 at risk EG00117 affected285 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00036 affected581 at risk EG0016 affected285 at risk
Weight decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG000115 affected581 at risk EG00125 affected285 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG000237 affected581 at risk EG00152 affected285 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00032 affected581 at risk EG0015 affected285 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00035 affected581 at risk EG0018 affected285 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00056 affected581 at risk EG00126 affected285 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00087 affected581 at risk EG00158 affected285 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00062 affected581 at risk EG00145 affected285 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00021 affected581 at risk EG00116 affected285 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00032 affected581 at risk EG00113 affected285 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00037 affected581 at risk EG00114 affected285 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00075 affected581 at risk EG00138 affected285 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00049 affected581 at risk EG00116 affected285 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG000170 affected581 at risk EG00127 affected285 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00050 affected581 at risk EG00117 affected285 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00040 affected581 at risk EG00119 affected285 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG00046 affected581 at risk EG00115 affected285 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00046 affected581 at risk EG00112 affected285 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00071 affected581 at risk EG00118 affected285 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00057 affected581 at risk EG0013 affected285 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00060 affected581 at risk EG00118 affected285 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG000172 affected581 at risk EG0018 affected285 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00041 affected581 at risk EG0014 affected285 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00051 affected581 at risk EG00117 affected285 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00033 affected581 at risk EG0014 affected285 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00078 affected581 at risk EG0016 affected285 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG000150 affected581 at risk EG00117 affected285 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
BG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sunitinib and Prednisone	Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.			275	581	573	581
EG001	Placebo and Prednisone	Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.			86	285	256	285