Study of Zoledronic Acid for Patients With Hormone-sensit... | NCT00242567

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early Group	Experimental	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.	Drug: Zoledronic Acid
Delayed group	Experimental	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level.	Drug: Androgen Deprivation Therapy (ADT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic Acid	Drug	Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration. After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours. The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes.

Measure	Description	Time Frame
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer	Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.	18 months

Measure	Description	Time Frame
Overall Survival at 18 Months and 3 Years	Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.	month 18, year 3
Time to Occurrence of Skeletal Related Event or Death

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Adelaide			Australia
Novartis Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
FG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

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

Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer

Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.

The ITT Population will consist of all patients randomized to treatment.

Posted

Number

participants

18 months

ID	Title	Description
OG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
OG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Units	Counts
Participants	OG000259 OG001263

Title

Denominators

Categories

Patients with event (s)

Title	Measurements
	OG00058 OG00149

Patients without event (censored)

Title	Measurements
	OG000

Secondary

Overall Survival at 18 Months and 3 Years

Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.

The ITT Population will consist of all patients randomized to treatment.

Posted

Number

participants

month 18, year 3

ID	Title	Description
OG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
OG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Units	Counts
Participants	OG000

Secondary

Time to Occurrence of Skeletal Related Event or Death

Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.

The ITT Population consisted of all patients randomized to treatment.

Posted

Median

95% Confidence Interval

Days

18 Months

ID	Title	Description
OG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
OG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Units	Counts
Participants	OG000

Secondary

Skeletal-related Event(SRE)-Free Survival

Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.

The ITT Population consisted of all patients randomized to treatment.

Posted

Median

95% Confidence Interval

Days

36 months

ID	Title	Description
OG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
OG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Units	Counts
Participants	OG000

Secondary

Time to Occurrence of Skeletal Related Event or Death

Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.

The ITT Population consisted of all patients randomized to treatment.

Posted

Median

95% Confidence Interval

Days

36 Months

ID	Title	Description
OG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
OG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0007 affected259 at risk EG00111 affected263 at risk EG0027 affected191 at risk EG0034 affected72 at risk
BONE MARROW FAILURE	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0020 affected191 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PROTEIN DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
ANGINA UNSTABLE	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
ATRIAL FLUTTER	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0013 affected263 at risk EG0023 affected191 at risk EG003
CARDIAC DISCOMFORT	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0013 affected263 at risk EG0021 affected191 at risk EG003
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CARDIOTOXICITY	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
LEFT VENTRICULAR HYPERTROPHY	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
SINUS TACHYCARDIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PHIMOSIS	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GOITRE	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CATARACT	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CATARACT NUCLEAR	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DIPLOPIA	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
EYE PAIN	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
OPHTHALMOPLEGIA	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ORBITAL OEDEMA	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
RETINAL DETACHMENT	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
VISION BLURRED	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
VISUAL IMPAIRMENT	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
ANAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CAECITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
DENTAL CARIES	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
DUODENAL ULCER PERFORATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MELAENA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PEPTIC ULCER	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PROCTITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
REFLUX OESOPHAGITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
ABASIA	General disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ASTHENIA	General disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0016 affected263 at risk EG0024 affected191 at risk EG003
CATHETER SITE PAIN	General disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CHEST DISCOMFORT	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CHEST PAIN	General disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
CHILLS	General disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CONCOMITANT DISEASE PROGRESSION	General disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0013 affected263 at risk EG0023 affected191 at risk EG003
DEATH	General disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0015 affected263 at risk EG0022 affected191 at risk EG003
DISEASE PROGRESSION	General disorders	MedDRA	Systematic Assessment	EG00025 affected259 at risk EG00116 affected263 at risk EG00210 affected191 at risk EG003
DRUG INEFFECTIVE	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
FACE OEDEMA	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
FATIGUE	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0014 affected263 at risk EG0024 affected191 at risk EG003
FEELING COLD	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
GENERALISED OEDEMA	General disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
MALAISE	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MUCOSAL INFLAMMATION	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MULTI-ORGAN DISORDER	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
MULTI-ORGAN FAILURE	General disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0013 affected263 at risk EG0021 affected191 at risk EG003
PAIN	General disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
PELVIC MASS	General disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PERFORMANCE STATUS DECREASED	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
SUPRAPUBIC PAIN	General disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ULCER	General disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BILIARY DILATATION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BUDD-CHIARI SYNDROME	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CHOLANGITIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
HEPATIC INFARCTION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HEPATIC LESION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HEPATOMEGALY	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
HEPATORENAL FAILURE	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HEPATORENAL SYNDROME	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
JAUNDICE	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PORTAL HYPERTENSION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BRONCHOPNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0014 affected263 at risk EG0021 affected191 at risk EG003
CARBUNCLE	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CELLULITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DIARRHOEA INFECTIOUS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ECZEMA INFECTED	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
ENTEROCOLITIS INFECTIOUS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
INFECTED SKIN ULCER	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
INFLUENZA	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
LOBAR PNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0013 affected263 at risk EG0023 affected191 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
LUNG INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
NECROTISING FASCIITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
NOSOCOMIAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ORAL CANDIDIASIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
OROPHARYNGITIS FUNGAL	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
OSTEOMYELITIS CHRONIC	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
PNEUMONIA PRIMARY ATYPICAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
RECTAL ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
SEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0015 affected263 at risk EG0025 affected191 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
SINUSITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
SKIN INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
STAPHYLOCOCCAL SKIN INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected259 at risk EG0016 affected263 at risk EG0025 affected191 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
VIRAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
GASTROENTERITIS RADIATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PENIS INJURY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
SKELETAL INJURY	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0013 affected263 at risk EG0023 affected191 at risk EG003
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
WOUND	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BLOOD ALBUMIN DECREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD CREATINE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD CREATININE	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD MAGNESIUM INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD PHOSPHORUS INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD POTASSIUM DECREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD POTASSIUM INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BLOOD TESTOSTERONE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0020 affected191 at risk EG003
BONE SCAN ABNORMAL	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ELECTROCARDIOGRAM ABNORMAL	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ELECTROCARDIOGRAM ST-T CHANGE	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HEPATITIS C POSITIVE	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
PROSTATIC SPECIFIC ANTIGEN INCREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
PROTEIN TOTAL DECREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
TROPONIN INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
URINE OUTPUT DECREASED	Investigations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CACHEXIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0014 affected263 at risk EG0024 affected191 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
FLUID INTAKE REDUCED	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
GOUT	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HYPOPHAGIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
MALNUTRITION	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
MARASMUS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
TYPE 1 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0016 affected263 at risk EG0022 affected191 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0014 affected263 at risk EG0024 affected191 at risk EG003
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MOBILITY DECREASED	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BILE DUCT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BONE MARROW TUMOUR CELL INFILTRATION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BONE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
BRONCHIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HEAD AND NECK CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
LIP AND/OR ORAL CAVITY CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0015 affected263 at risk EG0021 affected191 at risk EG003
METASTASES TO BONE MARROW	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0012 affected263 at risk EG0020 affected191 at risk EG003
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
METASTASES TO LYMPH NODES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
METASTASES TO NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
METASTASES TO SPINE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
METASTASIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
METASTATIC PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
NEUROENDOCRINE TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
OESOPHAGEAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ORAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PANCOAST'S TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00022 affected259 at risk EG00122 affected263 at risk EG00213 affected191 at risk EG003
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0018 affected263 at risk EG0025 affected191 at risk EG003
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
SQUAMOUS CELL CARCINOMA OF THE CERVIX	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
APHASIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
BASAL GANGLIA HAEMORRHAGE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CAUDA EQUINA SYNDROME	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CEREBRAL ARTERY OCCLUSION	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CEREBRAL ARTERY STENOSIS	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0014 affected263 at risk EG0024 affected191 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0012 affected263 at risk EG0020 affected191 at risk EG003
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0013 affected263 at risk EG0022 affected191 at risk EG003
COMA HEPATIC	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
COMA URAEMIC	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CONVULSION	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
DEMENTIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DIABETIC MONONEUROPATHY	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
DYSSTASIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
FACIAL PALSY	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
GUILLAIN-BARRE SYNDROME	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HEADACHE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
HORNER'S SYNDROME	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HYPOGLYCAEMIC COMA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
INTRACRANIAL HAEMATOMA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
LACUNAR INFARCTION	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
PARAPARESIS	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PARAPLEGIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0013 affected263 at risk EG0023 affected191 at risk EG003
SPINAL MENINGEAL CYST	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
DISORIENTATION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ANURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
AZOTAEMIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
BLADDER NECK OBSTRUCTION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
BLADDER OBSTRUCTION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CALCULUS BLADDER	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
CALCULUS URETERIC	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0013 affected263 at risk EG0020 affected191 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
NOCTURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
POLYURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
PYELOCALIECTASIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0014 affected263 at risk EG0024 affected191 at risk EG003
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
RENAL INFARCT	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
URETERAL DISORDER	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
URETHRAL DILATATION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
URINARY BLADDER HAEMORRHAGE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0016 affected263 at risk EG0023 affected191 at risk EG003
URINARY TRACT DISORDER	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0012 affected263 at risk EG0022 affected191 at risk EG003
BREAST PAIN	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PENILE PAIN	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PROSTATOMEGALY	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PULMONARY INFARCTION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected259 at risk EG0012 affected263 at risk EG0021 affected191 at risk EG003
STRIDOR	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HAEMORRHAGE SUBCUTANEOUS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
TRANSURETHRAL PROSTATECTOMY	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
AORTIC ANEURYSM	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
ARTERIAL STENOSIS LIMB	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG0012 affected263 at risk EG0020 affected191 at risk EG003
EXTRINSIC VASCULAR COMPRESSION	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0020 affected191 at risk EG003
HAEMORRHAGE	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0011 affected263 at risk EG0021 affected191 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003
SHOCK	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0010 affected263 at risk EG0020 affected191 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00039 affected259 at risk EG00130 affected263 at risk EG00212 affected191 at risk EG00318 affected72 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected259 at risk EG0016 affected263 at risk EG0021 affected191 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected259 at risk EG0014 affected263 at risk EG0020 affected191 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG00110 affected263 at risk EG0026 affected191 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 affected259 at risk EG00114 affected263 at risk EG0029 affected191 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00013 affected259 at risk EG0014 affected263 at risk EG0022 affected191 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00046 affected259 at risk EG00153 affected263 at risk EG00233 affected191 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00027 affected259 at risk EG00123 affected263 at risk EG00217 affected191 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 affected259 at risk EG0017 affected263 at risk EG0023 affected191 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00030 affected259 at risk EG00128 affected263 at risk EG00214 affected191 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00023 affected259 at risk EG00112 affected263 at risk EG0026 affected191 at risk EG003
ASTHENIA	General disorders	MedDRA	Systematic Assessment	EG00017 affected259 at risk EG00113 affected263 at risk EG0026 affected191 at risk EG003
FATIGUE	General disorders	MedDRA	Systematic Assessment	EG00031 affected259 at risk EG00121 affected263 at risk EG0029 affected191 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA	Systematic Assessment	EG00028 affected259 at risk EG00112 affected263 at risk EG0026 affected191 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA	Systematic Assessment	EG00029 affected259 at risk EG00123 affected263 at risk EG00214 affected191 at risk EG003
PAIN	General disorders	MedDRA	Systematic Assessment	EG00015 affected259 at risk EG00112 affected263 at risk EG0028 affected191 at risk EG003
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG00030 affected259 at risk EG0018 affected263 at risk EG0023 affected191 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG00011 affected259 at risk EG00114 affected263 at risk EG00211 affected191 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA	Systematic Assessment	EG00019 affected259 at risk EG00117 affected263 at risk EG00211 affected191 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG00028 affected259 at risk EG00120 affected263 at risk EG00214 affected191 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected259 at risk EG00122 affected263 at risk EG00213 affected191 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00016 affected259 at risk EG00117 affected263 at risk EG00211 affected191 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected259 at risk EG00110 affected263 at risk EG0026 affected191 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA	Systematic Assessment	EG00056 affected259 at risk EG00127 affected263 at risk EG00218 affected191 at risk EG003
PROSTATIC SPECIFIC ANTIGEN INCREASED	Investigations	MedDRA	Systematic Assessment	EG00060 affected259 at risk EG00161 affected263 at risk EG00226 affected191 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA	Systematic Assessment	EG00015 affected259 at risk EG00119 affected263 at risk EG00212 affected191 at risk EG003
WEIGHT INCREASED	Investigations	MedDRA	Systematic Assessment	EG0007 affected259 at risk EG00110 affected263 at risk EG0026 affected191 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00035 affected259 at risk EG00124 affected263 at risk EG00212 affected191 at risk EG003
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00033 affected259 at risk EG00111 affected263 at risk EG0024 affected191 at risk EG003
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00015 affected259 at risk EG0016 affected263 at risk EG0021 affected191 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00053 affected259 at risk EG00146 affected263 at risk EG00228 affected191 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00061 affected259 at risk EG00154 affected263 at risk EG00228 affected191 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00034 affected259 at risk EG00130 affected263 at risk EG00218 affected191 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00015 affected259 at risk EG0016 affected263 at risk EG0023 affected191 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected259 at risk EG00114 affected263 at risk EG0027 affected191 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 affected259 at risk EG00120 affected263 at risk EG00212 affected191 at risk EG003
MUSCULOSKELETAL DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0018 affected263 at risk EG0023 affected191 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00031 affected259 at risk EG00126 affected263 at risk EG00217 affected191 at risk EG003
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0017 affected263 at risk EG0022 affected191 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00018 affected259 at risk EG00115 affected263 at risk EG0029 affected191 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected259 at risk EG0017 affected263 at risk EG0022 affected191 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00036 affected259 at risk EG00142 affected263 at risk EG00218 affected191 at risk EG003
METASTATIC PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG00111 affected263 at risk EG0027 affected191 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00011 affected259 at risk EG00113 affected263 at risk EG0024 affected191 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA	Systematic Assessment	EG00018 affected259 at risk EG00117 affected263 at risk EG00211 affected191 at risk EG003
HEADACHE	Nervous system disorders	MedDRA	Systematic Assessment	EG00019 affected259 at risk EG0018 affected263 at risk EG0025 affected191 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected259 at risk EG0015 affected263 at risk EG0021 affected191 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA	Systematic Assessment	EG00016 affected259 at risk EG0019 affected263 at risk EG0025 affected191 at risk EG003
DEPRESSED MOOD	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 affected259 at risk EG0014 affected263 at risk EG0020 affected191 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA	Systematic Assessment	EG00019 affected259 at risk EG00118 affected263 at risk EG0029 affected191 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00017 affected259 at risk EG00115 affected263 at risk EG0029 affected191 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00017 affected259 at risk EG00111 affected263 at risk EG0025 affected191 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected259 at risk EG0015 affected263 at risk EG0021 affected191 at risk EG003
NOCTURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00016 affected259 at risk EG00113 affected263 at risk EG0025 affected191 at risk EG003
POLLAKIURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00010 affected259 at risk EG0019 affected263 at risk EG0025 affected191 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0009 affected259 at risk EG0017 affected263 at risk EG0022 affected191 at risk EG003
PELVIC PAIN	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0007 affected259 at risk EG0017 affected263 at risk EG0022 affected191 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00023 affected259 at risk EG00117 affected263 at risk EG00212 affected191 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00011 affected259 at risk EG00118 affected263 at risk EG0029 affected191 at risk EG003
HOT FLUSH	Vascular disorders	MedDRA	Systematic Assessment	EG00018 affected259 at risk EG00124 affected263 at risk EG00215 affected191 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG00014 affected259 at risk EG00111 affected263 at risk EG0024 affected191 at risk EG003

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
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006727	Hormone Antagonists
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

ID	Title	Description
BG000	Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
BG001	Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Early Group	Early Group	121	259	220	259
EG001	Delayed Group (Overall)	Delayed Group (Overall)	104	263	197	263
EG002	Delayed Group (No Zometa)	Delayed Group (No Zometa)	67	191	135	191
EG003	Delayed Group (Zometa)	Delayed Group (Zometa)	37	72	62	72