Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00242567
Collaborator
(none)
522
27
2
73
19.3
0.3
Study Details
Study Description
Brief Summary
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
522 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Jan 1, 2012
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early Group Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. |
Drug: Zoledronic Acid
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.
|
| Experimental: 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 Serum Prostate-specific Antigen (PSA) level. |
Drug: Androgen Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.
|
Outcome Measures
Primary Outcome Measures
- Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer [18 months]
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.
Secondary Outcome Measures
- Overall Survival at 18 Months and 3 Years [month 18, year 3]
Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.
- Time to Occurrence of Skeletal Related Event or Death [18 Months]
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.
- Skeletal-related Event(SRE)-Free Survival [36 months]
Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.
- Time to Occurrence of Skeletal Related Event or Death [36 Months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
prostate cancer
-
at least one bone metastasis
-
receiving or about to receive androgen deprivation therapy (ADT)
Exclusion Criteria:
-
previous ADT failure
-
previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
-
abnormal renal function
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Adelaide | Australia | ||
| 2 | Novartis Investigative Site | Brisbane | Australia | ||
| 3 | Novartis Investigative Site | Melbourne | Australia | ||
| 4 | Novartis Investigative Site | Port Macquarie | Australia | ||
| 5 | Novartis Investigative Site | Sydney | Australia | ||
| 6 | Novartis Investigative Site | Porto Alegre | Brazil | ||
| 7 | Novartis Investigative Site | Santo Andre | Brazil | ||
| 8 | Novartis Investigative Site | Sao Paulo | Brazil | ||
| 9 | Novartis Investigative Site | Beijing | China | ||
| 10 | Novartis Investigative Site | Chongqing | China | ||
| 11 | Novartis Investigative Site | Shanghai | China | ||
| 12 | Novartis Investigative Site | Busan | Korea, Republic of | ||
| 13 | Novartis Investigative Site | Kyunggi-do | Korea, Republic of | ||
| 14 | Novartis Investigative Site | Seoul | Korea, Republic of | ||
| 15 | Novartis Investigative Site | Kuwait | Kuwait | ||
| 16 | Novartis Investigative Site | Beirut | Lebanon | ||
| 17 | Novartis Investigative Site | Auckland | New Zealand | ||
| 18 | Novartis Investigative Site | Christchurch | New Zealand | ||
| 19 | Novartis Investigative Site | Hamilton | New Zealand | ||
| 20 | Novartis Investigative Site | Tauranga | New Zealand | ||
| 21 | Novartis Investigative Site | Wellington | New Zealand | ||
| 22 | Novartis Investigative Site | Riyadh | Saudi Arabia | ||
| 23 | Novartis Investigative Site | Taichung | Taiwan | ||
| 24 | Novartis Investigative Site | Taipei | Taiwan | ||
| 25 | Novartis Investigative Site | Taoyuan | Taiwan | ||
| 26 | Novartis Investigative Site | Bangkok | Thailand | ||
| 27 | Novartis Investigative Site | Songkhla | Thailand |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00242567
Other Study ID Numbers:
- CZOL446E2432
First Posted:
Oct 20, 2005
Last Update Posted:
May 7, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 552 patients enrolled, but 30 patients were excluded due to GCP issues in one country. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Early Group | Delayed Group |
|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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. |
| Period Title: Overall Study | ||
| STARTED | 259 | 263 |
| Received at Least 1 Dose of Study Drug | 259 | 72 |
| Never Received Study Drug | 0 | 191 |
| COMPLETED | 93 | 123 |
| NOT COMPLETED | 166 | 140 |
Baseline Characteristics
| Arm/Group Title | Early Group | Delayed Group | Total |
|---|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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 of all reporting groups |
| Overall Participants | 259 | 263 | 522 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
69.4
(8.46)
|
70.2
(8.26)
|
69.8
(8.37)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
259
100%
|
263
100%
|
522
100%
|
Outcome Measures
| Title | Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer |
|---|---|
| Description | 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. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population will consist of all patients randomized to treatment. |
| Arm/Group Title | Early Group | Delayed Group |
|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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. |
| Measure Participants | 259 | 263 |
| Patients with event (s) |
58
22.4%
|
49
18.6%
|
| Patients without event (censored) |
201
77.6%
|
214
81.4%
|
| Title | Overall Survival at 18 Months and 3 Years |
|---|---|
| Description | Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. |
| Time Frame | month 18, year 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population will consist of all patients randomized to treatment. |
| Arm/Group Title | Early Group | Delayed Group |
|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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. |
| Measure Participants | 259 | 263 |
| Patients with event (s) - 18 months |
31
12%
|
21
8%
|
| Patients without event - 18 months |
228
88%
|
242
92%
|
| Patients with event (s) - 36 months |
49
18.9%
|
44
16.7%
|
| Patients without event - 36 months |
210
81.1%
|
219
83.3%
|
| Title | Time to Occurrence of Skeletal Related Event or Death |
|---|---|
| Description | 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. |
| Time Frame | 18 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all patients randomized to treatment. |
| Arm/Group Title | Early Group | Delayed Group |
|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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. |
| Measure Participants | 259 | 263 |
| Median (95% Confidence Interval) [Days] |
NA
|
NA
|
| Title | Skeletal-related Event(SRE)-Free Survival |
|---|---|
| Description | Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored. |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all patients randomized to treatment. |
| Arm/Group Title | Early Group | Delayed Group |
|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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. |
| Measure Participants | 259 | 263 |
| Median (95% Confidence Interval) [Days] |
NA
|
NA
|
| Title | Time to Occurrence of Skeletal Related Event or Death |
|---|---|
| Description | 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. |
| Time Frame | 36 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT Population consisted of all patients randomized to treatment. |
| Arm/Group Title | Early Group | Delayed Group |
|---|---|---|
| Arm/Group Description | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. | 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. |
| Measure Participants | 259 | 263 |
| Median (95% Confidence Interval) [Days] |
NA
|
NA
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Early Group | Delayed Group (Overall) | Delayed Group (No Zometa) | Delayed Group (Zometa) | ||||
| Arm/Group Description | Early Group | Delayed Group (Overall) | Delayed Group (No Zometa) | Delayed Group (Zometa) | ||||
All Cause Mortality |
||||||||
| Early Group | Delayed Group (Overall) | Delayed Group (No Zometa) | Delayed Group (Zometa) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Early Group | Delayed Group (Overall) | Delayed Group (No Zometa) | Delayed Group (Zometa) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 121/259 (46.7%) | 104/263 (39.5%) | 67/191 (35.1%) | 37/72 (51.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| ANAEMIA | 7/259 (2.7%) | 11/263 (4.2%) | 7/191 (3.7%) | 4/72 (5.6%) | ||||
| BONE MARROW FAILURE | 1/259 (0.4%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| FEBRILE BONE MARROW APLASIA | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| LEUKOCYTOSIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| LEUKOPENIA | 3/259 (1.2%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| LYMPHADENOPATHY | 1/259 (0.4%) | 2/263 (0.8%) | 0/191 (0%) | 2/72 (2.8%) | ||||
| PANCYTOPENIA | 2/259 (0.8%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PROTEIN DEFICIENCY ANAEMIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| THROMBOCYTOPENIA | 1/259 (0.4%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| Cardiac disorders | ||||||||
| ACUTE MYOCARDIAL INFARCTION | 3/259 (1.2%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| ANGINA PECTORIS | 0/259 (0%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| ANGINA UNSTABLE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| ATRIAL FIBRILLATION | 1/259 (0.4%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| ATRIAL FLUTTER | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BUNDLE BRANCH BLOCK RIGHT | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CARDIAC ARREST | 2/259 (0.8%) | 3/263 (1.1%) | 3/191 (1.6%) | 0/72 (0%) | ||||
| CARDIAC DISCOMFORT | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CARDIAC FAILURE | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CARDIAC FAILURE ACUTE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CARDIAC FAILURE CHRONIC | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CARDIAC FAILURE CONGESTIVE | 1/259 (0.4%) | 3/263 (1.1%) | 1/191 (0.5%) | 2/72 (2.8%) | ||||
| CARDIO-RESPIRATORY ARREST | 3/259 (1.2%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CARDIOGENIC SHOCK | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CARDIOTOXICITY | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CORONARY ARTERY DISEASE | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CORONARY ARTERY STENOSIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HYPERTENSIVE HEART DISEASE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| LEFT VENTRICULAR HYPERTROPHY | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| MYOCARDIAL INFARCTION | 0/259 (0%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| PALPITATIONS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| SINUS TACHYCARDIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| PHIMOSIS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| TINNITUS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Endocrine disorders | ||||||||
| GOITRE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Eye disorders | ||||||||
| CATARACT | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CATARACT NUCLEAR | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DIPLOPIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| EYE PAIN | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| OPHTHALMOPLEGIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ORBITAL OEDEMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| RETINAL DETACHMENT | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| VISION BLURRED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| VISUAL IMPAIRMENT | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| ABDOMINAL DISTENSION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| ABDOMINAL PAIN | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| ANAL HAEMORRHAGE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CAECITIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CONSTIPATION | 3/259 (1.2%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| DENTAL CARIES | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DIARRHOEA | 3/259 (1.2%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| DUODENAL ULCER HAEMORRHAGE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| DUODENAL ULCER PERFORATION | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| DYSPHAGIA | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| GASTRITIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| GASTRITIS EROSIVE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| GASTROINTESTINAL HAEMORRHAGE | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| GASTROINTESTINAL INFLAMMATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| INGUINAL HERNIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| INTESTINAL OBSTRUCTION | 2/259 (0.8%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| INTESTINAL PERFORATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MELAENA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| MOUTH ULCERATION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| NAUSEA | 2/259 (0.8%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| OESOPHAGEAL VARICES HAEMORRHAGE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PANCREATITIS ACUTE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PEPTIC ULCER | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PROCTITIS | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| REFLUX OESOPHAGITIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| UPPER GASTROINTESTINAL HAEMORRHAGE | 0/259 (0%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| VOMITING | 7/259 (2.7%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| General disorders | ||||||||
| ABASIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| ASTHENIA | 5/259 (1.9%) | 6/263 (2.3%) | 4/191 (2.1%) | 2/72 (2.8%) | ||||
| CATHETER SITE PAIN | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CHEST DISCOMFORT | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CHEST PAIN | 2/259 (0.8%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| CHILLS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CONCOMITANT DISEASE PROGRESSION | 2/259 (0.8%) | 3/263 (1.1%) | 3/191 (1.6%) | 0/72 (0%) | ||||
| DEATH | 4/259 (1.5%) | 5/263 (1.9%) | 2/191 (1%) | 3/72 (4.2%) | ||||
| DISEASE PROGRESSION | 25/259 (9.7%) | 16/263 (6.1%) | 10/191 (5.2%) | 6/72 (8.3%) | ||||
| DRUG INEFFECTIVE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| FACE OEDEMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| FATIGUE | 1/259 (0.4%) | 4/263 (1.5%) | 4/191 (2.1%) | 0/72 (0%) | ||||
| FEELING COLD | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| GAIT DISTURBANCE | 2/259 (0.8%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| GENERAL PHYSICAL HEALTH DETERIORATION | 2/259 (0.8%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| GENERALISED OEDEMA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| MALAISE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MUCOSAL INFLAMMATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MULTI-ORGAN DISORDER | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| MULTI-ORGAN FAILURE | 4/259 (1.5%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| NON-CARDIAC CHEST PAIN | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| OEDEMA PERIPHERAL | 2/259 (0.8%) | 3/263 (1.1%) | 1/191 (0.5%) | 2/72 (2.8%) | ||||
| PAIN | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| PELVIC MASS | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PERFORMANCE STATUS DECREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PYREXIA | 6/259 (2.3%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| SUPRAPUBIC PAIN | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ULCER | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| BILIARY DILATATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BUDD-CHIARI SYNDROME | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CHOLANGITIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CHOLANGITIS ACUTE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CHOLELITHIASIS | 0/259 (0%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| HEPATIC INFARCTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HEPATIC LESION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HEPATITIS TOXIC | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HEPATOMEGALY | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| HEPATORENAL FAILURE | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HEPATORENAL SYNDROME | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| JAUNDICE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PORTAL HYPERTENSION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| Infections and infestations | ||||||||
| ABSCESS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BRONCHITIS | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BRONCHOPNEUMONIA | 2/259 (0.8%) | 4/263 (1.5%) | 1/191 (0.5%) | 3/72 (4.2%) | ||||
| CARBUNCLE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CELLULITIS | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DIARRHOEA INFECTIOUS | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| DIVERTICULITIS | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ECZEMA INFECTED | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| ENTEROCOLITIS INFECTIOUS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ESCHERICHIA URINARY TRACT INFECTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| GASTROENTERITIS | 4/259 (1.5%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| GASTROENTERITIS VIRAL | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| INFECTED SKIN ULCER | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| INFECTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| INFLUENZA | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| LOBAR PNEUMONIA | 0/259 (0%) | 3/263 (1.1%) | 3/191 (1.6%) | 0/72 (0%) | ||||
| LOWER RESPIRATORY TRACT INFECTION | 3/259 (1.2%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| LUNG INFECTION | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| NECROTISING FASCIITIS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| NOSOCOMIAL INFECTION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| ORAL CANDIDIASIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| OROPHARYNGITIS FUNGAL | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| OSTEOMYELITIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| OSTEOMYELITIS CHRONIC | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PNEUMONIA | 8/259 (3.1%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| PNEUMONIA PRIMARY ATYPICAL | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| POSTOPERATIVE WOUND INFECTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| RECTAL ABSCESS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| RESPIRATORY TRACT INFECTION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| SEPSIS | 4/259 (1.5%) | 5/263 (1.9%) | 5/191 (2.6%) | 0/72 (0%) | ||||
| SEPTIC SHOCK | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| SINUSITIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| SKIN INFECTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| STAPHYLOCOCCAL SKIN INFECTION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| URINARY TRACT INFECTION | 7/259 (2.7%) | 6/263 (2.3%) | 5/191 (2.6%) | 1/72 (1.4%) | ||||
| UROSEPSIS | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| VIRAL INFECTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| WOUND INFECTION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| ANIMAL BITE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| FALL | 2/259 (0.8%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| FEMORAL NECK FRACTURE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| FEMUR FRACTURE | 0/259 (0%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| GASTROENTERITIS RADIATION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| HEAD INJURY | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HUMERUS FRACTURE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PENIS INJURY | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| POSTOPERATIVE THORACIC PROCEDURE COMPLICATION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| SKELETAL INJURY | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| SPINAL COMPRESSION FRACTURE | 1/259 (0.4%) | 3/263 (1.1%) | 3/191 (1.6%) | 0/72 (0%) | ||||
| SUBDURAL HAEMATOMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| WOUND | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| WOUND DEHISCENCE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Investigations | ||||||||
| BLOOD ALBUMIN DECREASED | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| BLOOD BILIRUBIN INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD CREATINE INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD CREATINE PHOSPHOKINASE INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD CREATININE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| BLOOD CREATININE INCREASED | 3/259 (1.2%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| BLOOD LACTATE DEHYDROGENASE INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD MAGNESIUM INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD PHOSPHORUS INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD POTASSIUM DECREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD POTASSIUM INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BLOOD TESTOSTERONE INCREASED | 0/259 (0%) | 2/263 (0.8%) | 0/191 (0%) | 2/72 (2.8%) | ||||
| BONE SCAN ABNORMAL | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ELECTROCARDIOGRAM ABNORMAL | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ELECTROCARDIOGRAM ST-T CHANGE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HAEMOGLOBIN DECREASED | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HEPATIC ENZYME INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HEPATITIS C POSITIVE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| INTERNATIONAL NORMALISED RATIO INCREASED | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| LYMPHOCYTE COUNT DECREASED | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PLATELET COUNT DECREASED | 0/259 (0%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| PROSTATIC SPECIFIC ANTIGEN INCREASED | 0/259 (0%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| PROTEIN TOTAL DECREASED | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| TROPONIN INCREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| URINE OUTPUT DECREASED | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| WEIGHT DECREASED | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| CACHEXIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DECREASED APPETITE | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DEHYDRATION | 4/259 (1.5%) | 4/263 (1.5%) | 4/191 (2.1%) | 0/72 (0%) | ||||
| DIABETES MELLITUS | 2/259 (0.8%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| DIABETES MELLITUS INADEQUATE CONTROL | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| FLUID INTAKE REDUCED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| GOUT | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| HYPERKALAEMIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HYPOALBUMINAEMIA | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HYPOCALCAEMIA | 2/259 (0.8%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| HYPOGLYCAEMIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HYPOKALAEMIA | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| HYPONATRAEMIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HYPOPHAGIA | 1/259 (0.4%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| HYPOPHOSPHATAEMIA | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| MALNUTRITION | 0/259 (0%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| MARASMUS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| METABOLIC ACIDOSIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| TYPE 1 DIABETES MELLITUS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| VITAMIN D DEFICIENCY | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| ARTHRALGIA | 6/259 (2.3%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BACK PAIN | 5/259 (1.9%) | 6/263 (2.3%) | 2/191 (1%) | 4/72 (5.6%) | ||||
| BONE PAIN | 3/259 (1.2%) | 4/263 (1.5%) | 4/191 (2.1%) | 0/72 (0%) | ||||
| INTERVERTEBRAL DISC DEGENERATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MOBILITY DECREASED | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MUSCULAR WEAKNESS | 4/259 (1.5%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| MUSCULOSKELETAL CHEST PAIN | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MUSCULOSKELETAL PAIN | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MYALGIA | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| OSTEOARTHRITIS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| OSTEONECROSIS | 5/259 (1.9%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PAIN IN EXTREMITY | 1/259 (0.4%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| PAIN IN JAW | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PATHOLOGICAL FRACTURE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| B-CELL LYMPHOMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BASAL CELL CARCINOMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BILE DUCT CANCER | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BLADDER TRANSITIONAL CELL CARCINOMA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BONE MARROW TUMOUR CELL INFILTRATION | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BONE NEOPLASM | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BRAIN NEOPLASM | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| BRONCHIAL CARCINOMA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HEAD AND NECK CANCER | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| LIP AND/OR ORAL CAVITY CANCER | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| LUNG NEOPLASM MALIGNANT | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| MALIGNANT MELANOMA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| MALIGNANT NEOPLASM PROGRESSION | 5/259 (1.9%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| METASTASES TO BONE | 5/259 (1.9%) | 5/263 (1.9%) | 1/191 (0.5%) | 4/72 (5.6%) | ||||
| METASTASES TO BONE MARROW | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| METASTASES TO CENTRAL NERVOUS SYSTEM | 5/259 (1.9%) | 2/263 (0.8%) | 0/191 (0%) | 2/72 (2.8%) | ||||
| METASTASES TO LIVER | 3/259 (1.2%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| METASTASES TO LUNG | 1/259 (0.4%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| METASTASES TO LYMPH NODES | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| METASTASES TO NERVOUS SYSTEM | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| METASTASES TO SPINE | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| METASTASIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| METASTATIC NEOPLASM | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| METASTATIC PAIN | 0/259 (0%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| NEOPLASM PROGRESSION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| NEUROENDOCRINE TUMOUR | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| NON-SMALL CELL LUNG CANCER | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| OESOPHAGEAL CARCINOMA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| ORAL NEOPLASM | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PANCOAST'S TUMOUR | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PROSTATE CANCER | 22/259 (8.5%) | 22/263 (8.4%) | 13/191 (6.8%) | 9/72 (12.5%) | ||||
| PROSTATE CANCER METASTATIC | 6/259 (2.3%) | 8/263 (3%) | 5/191 (2.6%) | 3/72 (4.2%) | ||||
| RECTAL CANCER | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| RENAL CANCER | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| TRANSITIONAL CELL CARCINOMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Nervous system disorders | ||||||||
| ALTERED STATE OF CONSCIOUSNESS | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| APHASIA | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| BASAL GANGLIA HAEMORRHAGE | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CARPAL TUNNEL SYNDROME | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CAUDA EQUINA SYNDROME | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CEREBELLAR INFARCTION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CEREBRAL ARTERY OCCLUSION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CEREBRAL ARTERY STENOSIS | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CEREBRAL HAEMORRHAGE | 4/259 (1.5%) | 4/263 (1.5%) | 4/191 (2.1%) | 0/72 (0%) | ||||
| CEREBRAL INFARCTION | 3/259 (1.2%) | 2/263 (0.8%) | 0/191 (0%) | 2/72 (2.8%) | ||||
| CEREBRAL ISCHAEMIA | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| CEREBROVASCULAR ACCIDENT | 0/259 (0%) | 3/263 (1.1%) | 2/191 (1%) | 1/72 (1.4%) | ||||
| COMA HEPATIC | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| COMA URAEMIC | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CONVULSION | 1/259 (0.4%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| DEMENTIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DIABETIC MONONEUROPATHY | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| DYSSTASIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| FACIAL PALSY | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| GUILLAIN-BARRE SYNDROME | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HEADACHE | 0/259 (0%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| HORNER'S SYNDROME | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HYPOAESTHESIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HYPOGLYCAEMIC COMA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| INTRACRANIAL HAEMATOMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| LACUNAR INFARCTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| LOSS OF CONSCIOUSNESS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| PARAESTHESIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| PARAPARESIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PARAPLEGIA | 1/259 (0.4%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| SPINAL CORD COMPRESSION | 6/259 (2.3%) | 3/263 (1.1%) | 3/191 (1.6%) | 0/72 (0%) | ||||
| SPINAL MENINGEAL CYST | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| SYNCOPE | 3/259 (1.2%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| TRANSIENT ISCHAEMIC ATTACK | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| Psychiatric disorders | ||||||||
| ANXIETY | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CONFUSIONAL STATE | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DEPRESSION | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| DISORIENTATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| MENTAL STATUS CHANGES | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Renal and urinary disorders | ||||||||
| ANURIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| AZOTAEMIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| BLADDER NECK OBSTRUCTION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| BLADDER OBSTRUCTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CALCULUS BLADDER | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| CALCULUS URETERIC | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DYSURIA | 3/259 (1.2%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HAEMATURIA | 3/259 (1.2%) | 3/263 (1.1%) | 0/191 (0%) | 3/72 (4.2%) | ||||
| HYDRONEPHROSIS | 4/259 (1.5%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| NOCTURIA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| POLYURIA | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| PYELOCALIECTASIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| RENAL FAILURE | 5/259 (1.9%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| RENAL FAILURE ACUTE | 5/259 (1.9%) | 4/263 (1.5%) | 4/191 (2.1%) | 0/72 (0%) | ||||
| RENAL IMPAIRMENT | 1/259 (0.4%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| RENAL INFARCT | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| URETERAL DISORDER | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| URETERIC OBSTRUCTION | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| URETHRAL DILATATION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| URETHRAL STENOSIS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| URINARY BLADDER HAEMORRHAGE | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| URINARY INCONTINENCE | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| URINARY RETENTION | 5/259 (1.9%) | 6/263 (2.3%) | 3/191 (1.6%) | 3/72 (4.2%) | ||||
| URINARY TRACT DISORDER | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| URINARY TRACT OBSTRUCTION | 1/259 (0.4%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| BENIGN PROSTATIC HYPERPLASIA | 1/259 (0.4%) | 2/263 (0.8%) | 2/191 (1%) | 0/72 (0%) | ||||
| BREAST PAIN | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PENILE PAIN | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PROSTATOMEGALY | 1/259 (0.4%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| ASTHMA | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 4/259 (1.5%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| COUGH | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DYSPNOEA | 5/259 (1.9%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| DYSPNOEA EXERTIONAL | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| EMPHYSEMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HAEMOPTYSIS | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| INTERSTITIAL LUNG DISEASE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| LUNG DISORDER | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| PLEURAL EFFUSION | 1/259 (0.4%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PLEURITIC PAIN | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| PNEUMOTHORAX | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PRODUCTIVE COUGH | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| PULMONARY EMBOLISM | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PULMONARY INFARCTION | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| PULMONARY OEDEMA | 2/259 (0.8%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| RESPIRATORY ARREST | 0/259 (0%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| RESPIRATORY FAILURE | 8/259 (3.1%) | 2/263 (0.8%) | 1/191 (0.5%) | 1/72 (1.4%) | ||||
| STRIDOR | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| ERYTHEMA | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HAEMORRHAGE SUBCUTANEOUS | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Surgical and medical procedures | ||||||||
| TRANSURETHRAL PROSTATECTOMY | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| Vascular disorders | ||||||||
| AORTIC ANEURYSM | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| ARTERIAL STENOSIS LIMB | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| DEEP VEIN THROMBOSIS | 3/259 (1.2%) | 2/263 (0.8%) | 0/191 (0%) | 2/72 (2.8%) | ||||
| EXTRINSIC VASCULAR COMPRESSION | 0/259 (0%) | 1/263 (0.4%) | 0/191 (0%) | 1/72 (1.4%) | ||||
| HAEMORRHAGE | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HYPERTENSION | 4/259 (1.5%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| HYPERTENSIVE CRISIS | 0/259 (0%) | 1/263 (0.4%) | 1/191 (0.5%) | 0/72 (0%) | ||||
| HYPOTENSION | 2/259 (0.8%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
| SHOCK | 1/259 (0.4%) | 0/263 (0%) | 0/191 (0%) | 0/72 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Early Group | Delayed Group (Overall) | Delayed Group (No Zometa) | Delayed Group (Zometa) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 220/259 (84.9%) | 197/263 (74.9%) | 135/191 (70.7%) | 62/72 (86.1%) | ||||
| Blood and lymphatic system disorders | ||||||||
| ANAEMIA | 39/259 (15.1%) | 30/263 (11.4%) | 12/191 (6.3%) | 18/72 (25%) | ||||
| LYMPHADENOPATHY | 1/259 (0.4%) | 6/263 (2.3%) | 1/191 (0.5%) | 5/72 (6.9%) | ||||
| NEUTROPENIA | 2/259 (0.8%) | 4/263 (1.5%) | 0/191 (0%) | 4/72 (5.6%) | ||||
| THROMBOCYTOPENIA | 6/259 (2.3%) | 10/263 (3.8%) | 6/191 (3.1%) | 4/72 (5.6%) | ||||
| Gastrointestinal disorders | ||||||||
| ABDOMINAL PAIN | 10/259 (3.9%) | 14/263 (5.3%) | 9/191 (4.7%) | 5/72 (6.9%) | ||||
| ABDOMINAL PAIN UPPER | 13/259 (5%) | 4/263 (1.5%) | 2/191 (1%) | 2/72 (2.8%) | ||||
| CONSTIPATION | 46/259 (17.8%) | 53/263 (20.2%) | 33/191 (17.3%) | 20/72 (27.8%) | ||||
| DIARRHOEA | 27/259 (10.4%) | 23/263 (8.7%) | 17/191 (8.9%) | 6/72 (8.3%) | ||||
| DYSPEPSIA | 11/259 (4.2%) | 7/263 (2.7%) | 3/191 (1.6%) | 4/72 (5.6%) | ||||
| NAUSEA | 30/259 (11.6%) | 28/263 (10.6%) | 14/191 (7.3%) | 14/72 (19.4%) | ||||
| VOMITING | 23/259 (8.9%) | 12/263 (4.6%) | 6/191 (3.1%) | 6/72 (8.3%) | ||||
| General disorders | ||||||||
| ASTHENIA | 17/259 (6.6%) | 13/263 (4.9%) | 6/191 (3.1%) | 7/72 (9.7%) | ||||
| FATIGUE | 31/259 (12%) | 21/263 (8%) | 9/191 (4.7%) | 12/72 (16.7%) | ||||
| INFLUENZA LIKE ILLNESS | 28/259 (10.8%) | 12/263 (4.6%) | 6/191 (3.1%) | 6/72 (8.3%) | ||||
| OEDEMA PERIPHERAL | 29/259 (11.2%) | 23/263 (8.7%) | 14/191 (7.3%) | 9/72 (12.5%) | ||||
| PAIN | 15/259 (5.8%) | 12/263 (4.6%) | 8/191 (4.2%) | 4/72 (5.6%) | ||||
| PYREXIA | 30/259 (11.6%) | 8/263 (3%) | 3/191 (1.6%) | 5/72 (6.9%) | ||||
| Infections and infestations | ||||||||
| LOWER RESPIRATORY TRACT INFECTION | 11/259 (4.2%) | 14/263 (5.3%) | 11/191 (5.8%) | 3/72 (4.2%) | ||||
| NASOPHARYNGITIS | 19/259 (7.3%) | 17/263 (6.5%) | 11/191 (5.8%) | 6/72 (8.3%) | ||||
| UPPER RESPIRATORY TRACT INFECTION | 28/259 (10.8%) | 20/263 (7.6%) | 14/191 (7.3%) | 6/72 (8.3%) | ||||
| URINARY TRACT INFECTION | 15/259 (5.8%) | 22/263 (8.4%) | 13/191 (6.8%) | 9/72 (12.5%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| FALL | 16/259 (6.2%) | 17/263 (6.5%) | 11/191 (5.8%) | 6/72 (8.3%) | ||||
| SKIN LACERATION | 3/259 (1.2%) | 10/263 (3.8%) | 6/191 (3.1%) | 4/72 (5.6%) | ||||
| Investigations | ||||||||
| BLOOD CREATININE INCREASED | 56/259 (21.6%) | 27/263 (10.3%) | 18/191 (9.4%) | 9/72 (12.5%) | ||||
| PROSTATIC SPECIFIC ANTIGEN INCREASED | 60/259 (23.2%) | 61/263 (23.2%) | 26/191 (13.6%) | 35/72 (48.6%) | ||||
| WEIGHT DECREASED | 15/259 (5.8%) | 19/263 (7.2%) | 12/191 (6.3%) | 7/72 (9.7%) | ||||
| WEIGHT INCREASED | 7/259 (2.7%) | 10/263 (3.8%) | 6/191 (3.1%) | 4/72 (5.6%) | ||||
| Metabolism and nutrition disorders | ||||||||
| DECREASED APPETITE | 35/259 (13.5%) | 24/263 (9.1%) | 12/191 (6.3%) | 12/72 (16.7%) | ||||
| HYPOCALCAEMIA | 33/259 (12.7%) | 11/263 (4.2%) | 4/191 (2.1%) | 7/72 (9.7%) | ||||
| HYPOPHOSPHATAEMIA | 15/259 (5.8%) | 6/263 (2.3%) | 1/191 (0.5%) | 5/72 (6.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| ARTHRALGIA | 53/259 (20.5%) | 46/263 (17.5%) | 28/191 (14.7%) | 18/72 (25%) | ||||
| BACK PAIN | 61/259 (23.6%) | 54/263 (20.5%) | 28/191 (14.7%) | 26/72 (36.1%) | ||||
| BONE PAIN | 34/259 (13.1%) | 30/263 (11.4%) | 18/191 (9.4%) | 12/72 (16.7%) | ||||
| MUSCLE SPASMS | 15/259 (5.8%) | 6/263 (2.3%) | 3/191 (1.6%) | 3/72 (4.2%) | ||||
| MUSCULAR WEAKNESS | 10/259 (3.9%) | 14/263 (5.3%) | 7/191 (3.7%) | 7/72 (9.7%) | ||||
| MUSCULOSKELETAL CHEST PAIN | 9/259 (3.5%) | 20/263 (7.6%) | 12/191 (6.3%) | 8/72 (11.1%) | ||||
| MUSCULOSKELETAL DISCOMFORT | 6/259 (2.3%) | 8/263 (3%) | 3/191 (1.6%) | 5/72 (6.9%) | ||||
| MUSCULOSKELETAL PAIN | 31/259 (12%) | 26/263 (9.9%) | 17/191 (8.9%) | 9/72 (12.5%) | ||||
| MUSCULOSKELETAL STIFFNESS | 6/259 (2.3%) | 7/263 (2.7%) | 2/191 (1%) | 5/72 (6.9%) | ||||
| MYALGIA | 18/259 (6.9%) | 15/263 (5.7%) | 9/191 (4.7%) | 6/72 (8.3%) | ||||
| NECK PAIN | 6/259 (2.3%) | 7/263 (2.7%) | 2/191 (1%) | 5/72 (6.9%) | ||||
| PAIN IN EXTREMITY | 36/259 (13.9%) | 42/263 (16%) | 18/191 (9.4%) | 24/72 (33.3%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| METASTATIC PAIN | 4/259 (1.5%) | 11/263 (4.2%) | 7/191 (3.7%) | 4/72 (5.6%) | ||||
| PROSTATE CANCER | 11/259 (4.2%) | 13/263 (4.9%) | 4/191 (2.1%) | 9/72 (12.5%) | ||||
| Nervous system disorders | ||||||||
| DIZZINESS | 18/259 (6.9%) | 17/263 (6.5%) | 11/191 (5.8%) | 6/72 (8.3%) | ||||
| HEADACHE | 19/259 (7.3%) | 8/263 (3%) | 5/191 (2.6%) | 3/72 (4.2%) | ||||
| HYPOAESTHESIA | 9/259 (3.5%) | 5/263 (1.9%) | 1/191 (0.5%) | 4/72 (5.6%) | ||||
| PARAESTHESIA | 16/259 (6.2%) | 9/263 (3.4%) | 5/191 (2.6%) | 4/72 (5.6%) | ||||
| Psychiatric disorders | ||||||||
| DEPRESSED MOOD | 4/259 (1.5%) | 4/263 (1.5%) | 0/191 (0%) | 4/72 (5.6%) | ||||
| INSOMNIA | 19/259 (7.3%) | 18/263 (6.8%) | 9/191 (4.7%) | 9/72 (12.5%) | ||||
| Renal and urinary disorders | ||||||||
| DYSURIA | 17/259 (6.6%) | 15/263 (5.7%) | 9/191 (4.7%) | 6/72 (8.3%) | ||||
| HAEMATURIA | 17/259 (6.6%) | 11/263 (4.2%) | 5/191 (2.6%) | 6/72 (8.3%) | ||||
| HYDRONEPHROSIS | 0/259 (0%) | 5/263 (1.9%) | 1/191 (0.5%) | 4/72 (5.6%) | ||||
| NOCTURIA | 16/259 (6.2%) | 13/263 (4.9%) | 5/191 (2.6%) | 8/72 (11.1%) | ||||
| POLLAKIURIA | 10/259 (3.9%) | 9/263 (3.4%) | 5/191 (2.6%) | 4/72 (5.6%) | ||||
| URINARY RETENTION | 9/259 (3.5%) | 7/263 (2.7%) | 2/191 (1%) | 5/72 (6.9%) | ||||
| Reproductive system and breast disorders | ||||||||
| PELVIC PAIN | 7/259 (2.7%) | 7/263 (2.7%) | 2/191 (1%) | 5/72 (6.9%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| COUGH | 23/259 (8.9%) | 17/263 (6.5%) | 12/191 (6.3%) | 5/72 (6.9%) | ||||
| DYSPNOEA | 11/259 (4.2%) | 18/263 (6.8%) | 9/191 (4.7%) | 9/72 (12.5%) | ||||
| Vascular disorders | ||||||||
| HOT FLUSH | 18/259 (6.9%) | 24/263 (9.1%) | 15/191 (7.9%) | 9/72 (12.5%) | ||||
| HYPERTENSION | 14/259 (5.4%) | 11/263 (4.2%) | 4/191 (2.1%) | 7/72 (9.7%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00242567
Other Study ID Numbers:
- CZOL446E2432
First Posted:
Oct 20, 2005
Last Update Posted:
May 7, 2014
Last Verified:
Apr 1, 2014