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Trial Outcomes & Findings for Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer (NCT NCT00242567)

NCT ID: NCT00242567

Last Updated: 2014-05-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

522 participants

Primary outcome timeframe

18 months

Results posted on

2014-05-07

Participant Flow

552 patients enrolled, but 30 patients were excluded due to GCP issues in one country.

Participant milestones

Participant milestones
Measure
Early Group
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
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.
Overall Study
STARTED
259
263
Overall Study
Received at Least 1 Dose of Study Drug
259
72
Overall Study
Never Received Study Drug
0
191
Overall Study
COMPLETED
93
123
Overall Study
NOT COMPLETED
166
140

Reasons for withdrawal

Reasons for withdrawal
Measure
Early Group
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
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.
Overall Study
Adverse Event
70
43
Overall Study
Disease Progression
17
22
Overall Study
Symptomatic deterioration
9
3
Overall Study
Lack of Efficacy
2
2
Overall Study
Lost to Follow-up
9
19
Overall Study
Withdrawal by Subject
33
28
Overall Study
Protocol Violation
12
12
Overall Study
Use of an inhibitor of bone resorption
0
2
Overall Study
Other
14
9

Baseline Characteristics

Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Early Group
n=259 Participants
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group
n=263 Participants
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.
Total
n=522 Participants
Total of all reporting groups
Age, Continuous
69.4 years
STANDARD_DEVIATION 8.46 • n=5 Participants
70.2 years
STANDARD_DEVIATION 8.26 • n=7 Participants
69.8 years
STANDARD_DEVIATION 8.37 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
259 Participants
n=5 Participants
263 Participants
n=7 Participants
522 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 18 months

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

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.

Outcome measures

Outcome measures
Measure
Early Group
n=259 Participants
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group
n=263 Participants
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.
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Patients with event (s)
58 participants
49 participants
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Patients without event (censored)
201 participants
214 participants

SECONDARY outcome

Timeframe: month 18, year 3

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

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

Outcome measures

Outcome measures
Measure
Early Group
n=259 Participants
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group
n=263 Participants
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.
Overall Survival at 18 Months and 3 Years
Patients without event - 36 months
210 participants
219 participants
Overall Survival at 18 Months and 3 Years
Patients with event (s) - 18 months
31 participants
21 participants
Overall Survival at 18 Months and 3 Years
Patients without event - 18 months
228 participants
242 participants
Overall Survival at 18 Months and 3 Years
Patients with event (s) - 36 months
49 participants
44 participants

SECONDARY outcome

Timeframe: 18 Months

Population: The ITT Population consisted of all patients randomized to treatment.

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.

Outcome measures

Outcome measures
Measure
Early Group
n=259 Participants
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group
n=263 Participants
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.
Time to Occurrence of Skeletal Related Event or Death
NA Days
Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 18 months
NA Days
Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 18 months

SECONDARY outcome

Timeframe: 36 months

Population: The ITT Population consisted of all patients randomized to treatment.

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

Outcome measures

Outcome measures
Measure
Early Group
n=259 Participants
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group
n=263 Participants
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.
Skeletal-related Event(SRE)-Free Survival
NA Days
Median time to event was not calculable due to less than 50% of patients had an event of SRE at 36 months
NA Days
Median time to event was not calculable due to less than 50% of patients had an event of SRE at 36 months

SECONDARY outcome

Timeframe: 36 Months

Population: The ITT Population consisted of all patients randomized to treatment.

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.

Outcome measures

Outcome measures
Measure
Early Group
n=259 Participants
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group
n=263 Participants
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.
Time to Occurrence of Skeletal Related Event or Death
NA Days
Interval 945.0 to
Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 36 months
NA Days
Median time to event was not calculable due to less than 50% of patients had an event of SRE or Death at 36 months

Adverse Events

Early Group

Serious events: 121 serious events
Other events: 220 other events
Deaths: 0 deaths

Delayed Group (Overall)

Serious events: 104 serious events
Other events: 197 other events
Deaths: 0 deaths

Delayed Group (No Zometa)

Serious events: 67 serious events
Other events: 135 other events
Deaths: 0 deaths

Delayed Group (Zometa)

Serious events: 37 serious events
Other events: 62 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Early Group
n=259 participants at risk
Early Group
Delayed Group (Overall)
n=263 participants at risk
Delayed Group (Overall)
Delayed Group (No Zometa)
n=191 participants at risk
Delayed Group (No Zometa)
Delayed Group (Zometa)
n=72 participants at risk
Delayed Group (Zometa)
Nervous system disorders
INTRACRANIAL HAEMATOMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
0.39%
1/259
1.1%
3/263
1.6%
3/191
0.00%
0/72
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Injury, poisoning and procedural complications
WOUND
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Blood and lymphatic system disorders
ANAEMIA
2.7%
7/259
4.2%
11/263
3.7%
7/191
5.6%
4/72
Blood and lymphatic system disorders
BONE MARROW FAILURE
0.39%
1/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Blood and lymphatic system disorders
LEUKOCYTOSIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Blood and lymphatic system disorders
LEUKOPENIA
1.2%
3/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Blood and lymphatic system disorders
LYMPHADENOPATHY
0.39%
1/259
0.76%
2/263
0.00%
0/191
2.8%
2/72
Blood and lymphatic system disorders
PANCYTOPENIA
0.77%
2/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Blood and lymphatic system disorders
PROTEIN DEFICIENCY ANAEMIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Blood and lymphatic system disorders
THROMBOCYTOPENIA
0.39%
1/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
1.2%
3/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
ANGINA PECTORIS
0.00%
0/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Cardiac disorders
ANGINA UNSTABLE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
ATRIAL FIBRILLATION
0.39%
1/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Cardiac disorders
ATRIAL FLUTTER
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Cardiac disorders
CARDIAC ARREST
0.77%
2/259
1.1%
3/263
1.6%
3/191
0.00%
0/72
Cardiac disorders
CARDIAC DISCOMFORT
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
CARDIAC FAILURE
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Cardiac disorders
CARDIAC FAILURE ACUTE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Cardiac disorders
CARDIAC FAILURE CHRONIC
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
0.39%
1/259
1.1%
3/263
0.52%
1/191
2.8%
2/72
Cardiac disorders
CARDIO-RESPIRATORY ARREST
1.2%
3/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Cardiac disorders
CARDIOGENIC SHOCK
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
CARDIOTOXICITY
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Cardiac disorders
CORONARY ARTERY DISEASE
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Cardiac disorders
CORONARY ARTERY STENOSIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Cardiac disorders
HYPERTENSIVE HEART DISEASE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Cardiac disorders
LEFT VENTRICULAR HYPERTROPHY
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
MYOCARDIAL INFARCTION
0.00%
0/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Cardiac disorders
PALPITATIONS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Cardiac disorders
SINUS TACHYCARDIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Congenital, familial and genetic disorders
PHIMOSIS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Ear and labyrinth disorders
TINNITUS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Endocrine disorders
GOITRE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Eye disorders
CATARACT
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Eye disorders
CATARACT NUCLEAR
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
DIPLOPIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
EYE PAIN
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
OPHTHALMOPLEGIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
ORBITAL OEDEMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
RETINAL DETACHMENT
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
VISION BLURRED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Eye disorders
VISUAL IMPAIRMENT
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
ABDOMINAL DISTENSION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
ABDOMINAL PAIN
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
ANAL HAEMORRHAGE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
CAECITIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
CONSTIPATION
1.2%
3/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Gastrointestinal disorders
DENTAL CARIES
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
DIARRHOEA
1.2%
3/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
DUODENAL ULCER PERFORATION
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Gastrointestinal disorders
DYSPHAGIA
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
GASTRITIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
GASTRITIS EROSIVE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
INGUINAL HERNIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
0.77%
2/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
INTESTINAL PERFORATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
MELAENA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Gastrointestinal disorders
MOUTH ULCERATION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Gastrointestinal disorders
NAUSEA
0.77%
2/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
PANCREATITIS ACUTE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
PEPTIC ULCER
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
PROCTITIS
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Gastrointestinal disorders
REFLUX OESOPHAGITIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
0.00%
0/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Gastrointestinal disorders
VOMITING
2.7%
7/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
General disorders
ABASIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
General disorders
ASTHENIA
1.9%
5/259
2.3%
6/263
2.1%
4/191
2.8%
2/72
General disorders
CATHETER SITE PAIN
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
General disorders
CHEST DISCOMFORT
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
CHEST PAIN
0.77%
2/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
General disorders
CHILLS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
General disorders
CONCOMITANT DISEASE PROGRESSION
0.77%
2/259
1.1%
3/263
1.6%
3/191
0.00%
0/72
General disorders
DEATH
1.5%
4/259
1.9%
5/263
1.0%
2/191
4.2%
3/72
General disorders
DISEASE PROGRESSION
9.7%
25/259
6.1%
16/263
5.2%
10/191
8.3%
6/72
General disorders
DRUG INEFFECTIVE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
FACE OEDEMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
FATIGUE
0.39%
1/259
1.5%
4/263
2.1%
4/191
0.00%
0/72
General disorders
FEELING COLD
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
GAIT DISTURBANCE
0.77%
2/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
0.77%
2/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
General disorders
GENERALISED OEDEMA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
General disorders
MALAISE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
MUCOSAL INFLAMMATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
MULTI-ORGAN DISORDER
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
General disorders
MULTI-ORGAN FAILURE
1.5%
4/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
General disorders
NON-CARDIAC CHEST PAIN
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
General disorders
OEDEMA PERIPHERAL
0.77%
2/259
1.1%
3/263
0.52%
1/191
2.8%
2/72
General disorders
PAIN
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
General disorders
PELVIC MASS
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
General disorders
PERFORMANCE STATUS DECREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
PYREXIA
2.3%
6/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
SUPRAPUBIC PAIN
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
General disorders
ULCER
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Hepatobiliary disorders
BILIARY DILATATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
BUDD-CHIARI SYNDROME
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Hepatobiliary disorders
CHOLANGITIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
CHOLANGITIS ACUTE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
CHOLELITHIASIS
0.00%
0/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Hepatobiliary disorders
HEPATIC INFARCTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
HEPATIC LESION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
HEPATITIS TOXIC
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Hepatobiliary disorders
HEPATOMEGALY
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Hepatobiliary disorders
HEPATORENAL FAILURE
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Hepatobiliary disorders
HEPATORENAL SYNDROME
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
JAUNDICE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Hepatobiliary disorders
PORTAL HYPERTENSION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Infections and infestations
ABSCESS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
BRONCHITIS
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
BRONCHOPNEUMONIA
0.77%
2/259
1.5%
4/263
0.52%
1/191
4.2%
3/72
Infections and infestations
CARBUNCLE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
CELLULITIS
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
DIARRHOEA INFECTIOUS
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Infections and infestations
DIVERTICULITIS
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
ECZEMA INFECTED
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Infections and infestations
ENTEROCOLITIS INFECTIOUS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
GASTROENTERITIS
1.5%
4/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Infections and infestations
GASTROENTERITIS VIRAL
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Infections and infestations
INFECTED SKIN ULCER
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
INFECTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
INFLUENZA
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
LOBAR PNEUMONIA
0.00%
0/259
1.1%
3/263
1.6%
3/191
0.00%
0/72
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
1.2%
3/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
LUNG INFECTION
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Infections and infestations
NECROTISING FASCIITIS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
NOSOCOMIAL INFECTION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
ORAL CANDIDIASIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
OROPHARYNGITIS FUNGAL
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
OSTEOMYELITIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
OSTEOMYELITIS CHRONIC
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
PNEUMONIA
3.1%
8/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
POSTOPERATIVE WOUND INFECTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
RECTAL ABSCESS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
RESPIRATORY TRACT INFECTION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
SEPSIS
1.5%
4/259
1.9%
5/263
2.6%
5/191
0.00%
0/72
Infections and infestations
SEPTIC SHOCK
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
SINUSITIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
SKIN INFECTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Infections and infestations
URINARY TRACT INFECTION
2.7%
7/259
2.3%
6/263
2.6%
5/191
1.4%
1/72
Infections and infestations
UROSEPSIS
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Infections and infestations
VIRAL INFECTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Infections and infestations
WOUND INFECTION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Injury, poisoning and procedural complications
ANIMAL BITE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Injury, poisoning and procedural complications
FALL
0.77%
2/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Injury, poisoning and procedural complications
FEMUR FRACTURE
0.00%
0/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Injury, poisoning and procedural complications
GASTROENTERITIS RADIATION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Injury, poisoning and procedural complications
HEAD INJURY
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Injury, poisoning and procedural complications
HUMERUS FRACTURE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Injury, poisoning and procedural complications
PENIS INJURY
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Injury, poisoning and procedural complications
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Injury, poisoning and procedural complications
SKELETAL INJURY
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Injury, poisoning and procedural complications
WOUND DEHISCENCE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Investigations
BLOOD ALBUMIN DECREASED
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Investigations
BLOOD BILIRUBIN INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD CREATINE INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD CREATININE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Investigations
BLOOD CREATININE INCREASED
1.2%
3/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD MAGNESIUM INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD PHOSPHORUS INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD POTASSIUM DECREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD POTASSIUM INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
BLOOD TESTOSTERONE INCREASED
0.00%
0/259
0.76%
2/263
0.00%
0/191
2.8%
2/72
Investigations
BONE SCAN ABNORMAL
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
ELECTROCARDIOGRAM ABNORMAL
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
ELECTROCARDIOGRAM ST-T CHANGE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
HAEMOGLOBIN DECREASED
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
HEPATIC ENZYME INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
HEPATITIS C POSITIVE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Investigations
LYMPHOCYTE COUNT DECREASED
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Investigations
PLATELET COUNT DECREASED
0.00%
0/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
0.00%
0/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Investigations
PROTEIN TOTAL DECREASED
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Investigations
TROPONIN INCREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
URINE OUTPUT DECREASED
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Investigations
WEIGHT DECREASED
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Metabolism and nutrition disorders
CACHEXIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Metabolism and nutrition disorders
DECREASED APPETITE
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Metabolism and nutrition disorders
DEHYDRATION
1.5%
4/259
1.5%
4/263
2.1%
4/191
0.00%
0/72
Metabolism and nutrition disorders
DIABETES MELLITUS
0.77%
2/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Metabolism and nutrition disorders
FLUID INTAKE REDUCED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Metabolism and nutrition disorders
GOUT
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Metabolism and nutrition disorders
HYPERKALAEMIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Metabolism and nutrition disorders
HYPOCALCAEMIA
0.77%
2/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Metabolism and nutrition disorders
HYPOGLYCAEMIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Metabolism and nutrition disorders
HYPONATRAEMIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Metabolism and nutrition disorders
HYPOPHAGIA
0.39%
1/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Metabolism and nutrition disorders
MALNUTRITION
0.00%
0/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Metabolism and nutrition disorders
MARASMUS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Musculoskeletal and connective tissue disorders
ARTHRALGIA
2.3%
6/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
BACK PAIN
1.9%
5/259
2.3%
6/263
1.0%
2/191
5.6%
4/72
Musculoskeletal and connective tissue disorders
BONE PAIN
1.2%
3/259
1.5%
4/263
2.1%
4/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
1.5%
4/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
MYALGIA
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
1.9%
5/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.39%
1/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Musculoskeletal and connective tissue disorders
PAIN IN JAW
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILE DUCT CANCER
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BONE MARROW TUMOUR CELL INFILTRATION
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BONE NEOPLASM
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRONCHIAL CARCINOMA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAD AND NECK CANCER
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIP AND/OR ORAL CAVITY CANCER
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
1.9%
5/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
1.9%
5/259
1.9%
5/263
0.52%
1/191
5.6%
4/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE MARROW
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
1.9%
5/259
0.76%
2/263
0.00%
0/191
2.8%
2/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
1.2%
3/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
0.39%
1/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LYMPH NODES
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO NERVOUS SYSTEM
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SPINE
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
0.00%
0/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE TUMOUR
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ORAL NEOPLASM
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCOAST'S TUMOUR
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
8.5%
22/259
8.4%
22/263
6.8%
13/191
12.5%
9/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
2.3%
6/259
3.0%
8/263
2.6%
5/191
4.2%
3/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE CERVIX
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
APHASIA
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
BASAL GANGLIA HAEMORRHAGE
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
CARPAL TUNNEL SYNDROME
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
CAUDA EQUINA SYNDROME
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
CEREBELLAR INFARCTION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
CEREBRAL ARTERY OCCLUSION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
CEREBRAL ARTERY STENOSIS
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
CEREBRAL HAEMORRHAGE
1.5%
4/259
1.5%
4/263
2.1%
4/191
0.00%
0/72
Nervous system disorders
CEREBRAL INFARCTION
1.2%
3/259
0.76%
2/263
0.00%
0/191
2.8%
2/72
Nervous system disorders
CEREBRAL ISCHAEMIA
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
CEREBROVASCULAR ACCIDENT
0.00%
0/259
1.1%
3/263
1.0%
2/191
1.4%
1/72
Nervous system disorders
COMA HEPATIC
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
COMA URAEMIC
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
CONVULSION
0.39%
1/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Nervous system disorders
DEMENTIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
DIABETIC MONONEUROPATHY
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
DYSSTASIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
FACIAL PALSY
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Nervous system disorders
GUILLAIN-BARRE SYNDROME
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
HEADACHE
0.00%
0/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Nervous system disorders
HORNER'S SYNDROME
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
HYPOAESTHESIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
HYPOGLYCAEMIC COMA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
LACUNAR INFARCTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
LOSS OF CONSCIOUSNESS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
PARAESTHESIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Nervous system disorders
PARAPARESIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
PARAPLEGIA
0.39%
1/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Nervous system disorders
SPINAL CORD COMPRESSION
2.3%
6/259
1.1%
3/263
1.6%
3/191
0.00%
0/72
Nervous system disorders
SPINAL MENINGEAL CYST
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
SYNCOPE
1.2%
3/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Psychiatric disorders
ANXIETY
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Psychiatric disorders
CONFUSIONAL STATE
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Psychiatric disorders
DEPRESSION
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Psychiatric disorders
DISORIENTATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Psychiatric disorders
MENTAL STATUS CHANGES
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
ANURIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
AZOTAEMIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
BLADDER NECK OBSTRUCTION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Renal and urinary disorders
BLADDER OBSTRUCTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
CALCULUS BLADDER
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
CALCULUS URETERIC
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
DYSURIA
1.2%
3/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
HAEMATURIA
1.2%
3/259
1.1%
3/263
0.00%
0/191
4.2%
3/72
Renal and urinary disorders
HYDRONEPHROSIS
1.5%
4/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Renal and urinary disorders
NOCTURIA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
POLYURIA
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
PYELOCALIECTASIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
RENAL FAILURE
1.9%
5/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
RENAL FAILURE ACUTE
1.9%
5/259
1.5%
4/263
2.1%
4/191
0.00%
0/72
Renal and urinary disorders
RENAL IMPAIRMENT
0.39%
1/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Renal and urinary disorders
RENAL INFARCT
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
URETERAL DISORDER
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Renal and urinary disorders
URETERIC OBSTRUCTION
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
URETHRAL DILATATION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
URETHRAL STENOSIS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Renal and urinary disorders
URINARY BLADDER HAEMORRHAGE
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Renal and urinary disorders
URINARY INCONTINENCE
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Renal and urinary disorders
URINARY RETENTION
1.9%
5/259
2.3%
6/263
1.6%
3/191
4.2%
3/72
Renal and urinary disorders
URINARY TRACT DISORDER
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
0.39%
1/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
0.39%
1/259
0.76%
2/263
1.0%
2/191
0.00%
0/72
Reproductive system and breast disorders
BREAST PAIN
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Reproductive system and breast disorders
PENILE PAIN
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Reproductive system and breast disorders
PROSTATOMEGALY
0.39%
1/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
ASTHMA
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1.5%
4/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
COUGH
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
1.9%
5/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
0.39%
1/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
PULMONARY INFARCTION
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
0.77%
2/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
0.00%
0/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
3.1%
8/259
0.76%
2/263
0.52%
1/191
1.4%
1/72
Respiratory, thoracic and mediastinal disorders
STRIDOR
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Skin and subcutaneous tissue disorders
ERYTHEMA
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Skin and subcutaneous tissue disorders
HAEMORRHAGE SUBCUTANEOUS
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Surgical and medical procedures
TRANSURETHRAL PROSTATECTOMY
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Vascular disorders
AORTIC ANEURYSM
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Vascular disorders
ARTERIAL STENOSIS LIMB
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Vascular disorders
DEEP VEIN THROMBOSIS
1.2%
3/259
0.76%
2/263
0.00%
0/191
2.8%
2/72
Vascular disorders
EXTRINSIC VASCULAR COMPRESSION
0.00%
0/259
0.38%
1/263
0.00%
0/191
1.4%
1/72
Vascular disorders
HAEMORRHAGE
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Vascular disorders
HYPERTENSION
1.5%
4/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Vascular disorders
HYPERTENSIVE CRISIS
0.00%
0/259
0.38%
1/263
0.52%
1/191
0.00%
0/72
Vascular disorders
HYPOTENSION
0.77%
2/259
0.00%
0/263
0.00%
0/191
0.00%
0/72
Vascular disorders
SHOCK
0.39%
1/259
0.00%
0/263
0.00%
0/191
0.00%
0/72

Other adverse events

Other adverse events
Measure
Early Group
n=259 participants at risk
Early Group
Delayed Group (Overall)
n=263 participants at risk
Delayed Group (Overall)
Delayed Group (No Zometa)
n=191 participants at risk
Delayed Group (No Zometa)
Delayed Group (Zometa)
n=72 participants at risk
Delayed Group (Zometa)
Blood and lymphatic system disorders
ANAEMIA
15.1%
39/259
11.4%
30/263
6.3%
12/191
25.0%
18/72
Blood and lymphatic system disorders
LYMPHADENOPATHY
0.39%
1/259
2.3%
6/263
0.52%
1/191
6.9%
5/72
Blood and lymphatic system disorders
NEUTROPENIA
0.77%
2/259
1.5%
4/263
0.00%
0/191
5.6%
4/72
Blood and lymphatic system disorders
THROMBOCYTOPENIA
2.3%
6/259
3.8%
10/263
3.1%
6/191
5.6%
4/72
Gastrointestinal disorders
ABDOMINAL PAIN
3.9%
10/259
5.3%
14/263
4.7%
9/191
6.9%
5/72
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
5.0%
13/259
1.5%
4/263
1.0%
2/191
2.8%
2/72
Gastrointestinal disorders
CONSTIPATION
17.8%
46/259
20.2%
53/263
17.3%
33/191
27.8%
20/72
Musculoskeletal and connective tissue disorders
NECK PAIN
2.3%
6/259
2.7%
7/263
1.0%
2/191
6.9%
5/72
Gastrointestinal disorders
DIARRHOEA
10.4%
27/259
8.7%
23/263
8.9%
17/191
8.3%
6/72
Gastrointestinal disorders
DYSPEPSIA
4.2%
11/259
2.7%
7/263
1.6%
3/191
5.6%
4/72
Gastrointestinal disorders
NAUSEA
11.6%
30/259
10.6%
28/263
7.3%
14/191
19.4%
14/72
Gastrointestinal disorders
VOMITING
8.9%
23/259
4.6%
12/263
3.1%
6/191
8.3%
6/72
General disorders
ASTHENIA
6.6%
17/259
4.9%
13/263
3.1%
6/191
9.7%
7/72
General disorders
FATIGUE
12.0%
31/259
8.0%
21/263
4.7%
9/191
16.7%
12/72
General disorders
INFLUENZA LIKE ILLNESS
10.8%
28/259
4.6%
12/263
3.1%
6/191
8.3%
6/72
General disorders
OEDEMA PERIPHERAL
11.2%
29/259
8.7%
23/263
7.3%
14/191
12.5%
9/72
General disorders
PAIN
5.8%
15/259
4.6%
12/263
4.2%
8/191
5.6%
4/72
General disorders
PYREXIA
11.6%
30/259
3.0%
8/263
1.6%
3/191
6.9%
5/72
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
4.2%
11/259
5.3%
14/263
5.8%
11/191
4.2%
3/72
Infections and infestations
NASOPHARYNGITIS
7.3%
19/259
6.5%
17/263
5.8%
11/191
8.3%
6/72
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
10.8%
28/259
7.6%
20/263
7.3%
14/191
8.3%
6/72
Infections and infestations
URINARY TRACT INFECTION
5.8%
15/259
8.4%
22/263
6.8%
13/191
12.5%
9/72
Injury, poisoning and procedural complications
FALL
6.2%
16/259
6.5%
17/263
5.8%
11/191
8.3%
6/72
Injury, poisoning and procedural complications
SKIN LACERATION
1.2%
3/259
3.8%
10/263
3.1%
6/191
5.6%
4/72
Investigations
BLOOD CREATININE INCREASED
21.6%
56/259
10.3%
27/263
9.4%
18/191
12.5%
9/72
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
23.2%
60/259
23.2%
61/263
13.6%
26/191
48.6%
35/72
Investigations
WEIGHT DECREASED
5.8%
15/259
7.2%
19/263
6.3%
12/191
9.7%
7/72
Investigations
WEIGHT INCREASED
2.7%
7/259
3.8%
10/263
3.1%
6/191
5.6%
4/72
Metabolism and nutrition disorders
DECREASED APPETITE
13.5%
35/259
9.1%
24/263
6.3%
12/191
16.7%
12/72
Metabolism and nutrition disorders
HYPOCALCAEMIA
12.7%
33/259
4.2%
11/263
2.1%
4/191
9.7%
7/72
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
5.8%
15/259
2.3%
6/263
0.52%
1/191
6.9%
5/72
Musculoskeletal and connective tissue disorders
ARTHRALGIA
20.5%
53/259
17.5%
46/263
14.7%
28/191
25.0%
18/72
Musculoskeletal and connective tissue disorders
BACK PAIN
23.6%
61/259
20.5%
54/263
14.7%
28/191
36.1%
26/72
Musculoskeletal and connective tissue disorders
BONE PAIN
13.1%
34/259
11.4%
30/263
9.4%
18/191
16.7%
12/72
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
5.8%
15/259
2.3%
6/263
1.6%
3/191
4.2%
3/72
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
3.9%
10/259
5.3%
14/263
3.7%
7/191
9.7%
7/72
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
3.5%
9/259
7.6%
20/263
6.3%
12/191
11.1%
8/72
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
2.3%
6/259
3.0%
8/263
1.6%
3/191
6.9%
5/72
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
12.0%
31/259
9.9%
26/263
8.9%
17/191
12.5%
9/72
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
2.3%
6/259
2.7%
7/263
1.0%
2/191
6.9%
5/72
Musculoskeletal and connective tissue disorders
MYALGIA
6.9%
18/259
5.7%
15/263
4.7%
9/191
8.3%
6/72
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
13.9%
36/259
16.0%
42/263
9.4%
18/191
33.3%
24/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
1.5%
4/259
4.2%
11/263
3.7%
7/191
5.6%
4/72
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
4.2%
11/259
4.9%
13/263
2.1%
4/191
12.5%
9/72
Nervous system disorders
DIZZINESS
6.9%
18/259
6.5%
17/263
5.8%
11/191
8.3%
6/72
Nervous system disorders
HEADACHE
7.3%
19/259
3.0%
8/263
2.6%
5/191
4.2%
3/72
Nervous system disorders
HYPOAESTHESIA
3.5%
9/259
1.9%
5/263
0.52%
1/191
5.6%
4/72
Nervous system disorders
PARAESTHESIA
6.2%
16/259
3.4%
9/263
2.6%
5/191
5.6%
4/72
Psychiatric disorders
DEPRESSED MOOD
1.5%
4/259
1.5%
4/263
0.00%
0/191
5.6%
4/72
Psychiatric disorders
INSOMNIA
7.3%
19/259
6.8%
18/263
4.7%
9/191
12.5%
9/72
Renal and urinary disorders
DYSURIA
6.6%
17/259
5.7%
15/263
4.7%
9/191
8.3%
6/72
Renal and urinary disorders
HAEMATURIA
6.6%
17/259
4.2%
11/263
2.6%
5/191
8.3%
6/72
Renal and urinary disorders
HYDRONEPHROSIS
0.00%
0/259
1.9%
5/263
0.52%
1/191
5.6%
4/72
Renal and urinary disorders
NOCTURIA
6.2%
16/259
4.9%
13/263
2.6%
5/191
11.1%
8/72
Renal and urinary disorders
POLLAKIURIA
3.9%
10/259
3.4%
9/263
2.6%
5/191
5.6%
4/72
Renal and urinary disorders
URINARY RETENTION
3.5%
9/259
2.7%
7/263
1.0%
2/191
6.9%
5/72
Reproductive system and breast disorders
PELVIC PAIN
2.7%
7/259
2.7%
7/263
1.0%
2/191
6.9%
5/72
Respiratory, thoracic and mediastinal disorders
COUGH
8.9%
23/259
6.5%
17/263
6.3%
12/191
6.9%
5/72
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
4.2%
11/259
6.8%
18/263
4.7%
9/191
12.5%
9/72
Vascular disorders
HOT FLUSH
6.9%
18/259
9.1%
24/263
7.9%
15/191
12.5%
9/72
Vascular disorders
HYPERTENSION
5.4%
14/259
4.2%
11/263
2.1%
4/191
9.7%
7/72

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER