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Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

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ClinicalTrials.gov Identifier: NCT00638690
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : May 16, 2013
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostatic Neoplasms
Interventions Drug: Placebo
Drug: Abiraterone acetate
Drug: Prednisone/prednisolone
Enrollment 1195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abiraterone Acetate Placebo
Hide Arm/Group Description Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression. Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Period Title: Overall Study
Started 797 398
Completed 116 56
Not Completed 681 342
Reason Not Completed
Death             655             335
Withdrawal by Subject             22             5
Lost to Follow-up             4             2
Arm/Group Title Abiraterone Acetate Placebo Total
Hide Arm/Group Description Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression. Placebo plus prednisone/prednisolone Total of all reporting groups
Overall Number of Baseline Participants 797 398 1195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 797 participants 398 participants 1195 participants
69.1  (8.4) 68.9  (8.61) 69  (8.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 797 participants 398 participants 1195 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
797
 100.0%
398
 100.0%
1195
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 797 participants 398 participants 1195 participants
Australia 69 35 104
Austria 11 1 12
Belgium 32 11 43
Canada 97 57 154
France 57 33 90
Germany 26 12 38
Hungary 5 2 7
Italy 21 12 33
Netherlands 4 2 6
Republic of Ireland 7 7 14
Spain 13 3 16
United Kingdom 119 61 180
United States 336 162 498
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate Placebo
Hide Arm/Group Description:
Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Overall Number of Participants Analyzed 797 398
Median (95% Confidence Interval)
Unit of Measure: Days
450.0
(430.0 to 470.0)
332.0
(310.0 to 366.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abiraterone Acetate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Nominal P-value is 0.0142 at interim analysis based on group sequential design.
Method Log Rank
Comments This was a stratified analysis.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.646
Confidence Interval (2-Sided) 95%
0.543 to 0.768
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
Hide Description The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate Placebo
Hide Arm/Group Description:
Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Overall Number of Participants Analyzed 797 398
Median (95% Confidence Interval)
Unit of Measure: Days
309.0
(255.0 to 421.0)
200.0
(170.0 to 254.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abiraterone Acetate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Nominal P-value = 0.05.
Method Log Rank
Comments This was a stratified analysis.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.580
Confidence Interval 95%
0.462 to 0.728
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
Hide Description A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate Placebo
Hide Arm/Group Description:
Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Overall Number of Participants Analyzed 797 398
Measure Type: Number
Unit of Measure: Participants
232 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abiraterone Acetate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal P-value = 0.05.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 5.266
Confidence Interval (2-Sided) 95%
3.459 to 8.018
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Radiographic Progression-free Survival
Hide Description Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate Placebo
Hide Arm/Group Description:
Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Overall Number of Participants Analyzed 797 398
Median (95% Confidence Interval)
Unit of Measure: Days
171.0
(169.0 to 192.0)
110.0
(88.0 to 168.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abiraterone Acetate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The nominal P-value = 0.05.
Method Log Rank
Comments This was a stratified analysis.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.673
Confidence Interval (2-Sided) 95%
0.585 to 0.776
Estimation Comments [Not Specified]
Time Frame 5 years
Adverse Event Reporting Description Following interim analysis of the study by the Independent Data Monitoring Committee in August 2010, the protocol was amended to provide for the unblinding of all study participants and the option for placebo participants to receive abiraterone acetate treatment; 67 placebo participants crossed over.
 
Arm/Group Title Abiraterone Acetate Placebo Placebo to Abiraterone Acetate
Hide Arm/Group Description Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression. Placebo plus prednisone/prednisolone Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
All-Cause Mortality
Abiraterone Acetate Placebo Placebo to Abiraterone Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abiraterone Acetate Placebo Placebo to Abiraterone Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   365/791 (46.14%)   175/394 (44.42%)   29/67 (43.28%) 
Blood and lymphatic system disorders       
Anaemia  1  26/791 (3.29%)  15/394 (3.81%)  1/67 (1.49%) 
Coagulopathy  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pancytopenia  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Thrombocytopenia  1  6/791 (0.76%)  1/394 (0.25%)  0/67 (0.00%) 
Febrile bone marrow aplasia  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Febrile neutropenia  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Neutropenia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cardiac disorders       
Bradycardia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Acute coronary syndrome  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Angina pectoris  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Atrial fibrillation  1  6/791 (0.76%)  3/394 (0.76%)  1/67 (1.49%) 
Atrioventricular block complete  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cardiac failure  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Cardiac failure congestive  1  4/791 (0.51%)  1/394 (0.25%)  0/67 (0.00%) 
Cardio-respiratory arrest  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cardiogenic shock  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Chest pain  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Left ventricular dysfunction  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Myocardial infarction  1  7/791 (0.88%)  1/394 (0.25%)  0/67 (0.00%) 
Pericardial effusion  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Supraventricular extrasystoles  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Supraventricular tachycardia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Tachycardia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Ear and labyrinth disorders       
Hypoacusis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Tinnitus  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Vertigo  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Endocrine disorders       
Hyperglycaemia  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Adrenal insufficiency  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Adrenal suppression  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Hyperthyroidism  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Eye disorders       
Blindness  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Cataract  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Diplopia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Keratitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Blindness unilateral  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Eye pain  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pupils unequal  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Retinal vein occlusion  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Vitreous haemorrhage  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Gastrointestinal disorders       
Constipation  1  5/791 (0.63%)  3/394 (0.76%)  0/67 (0.00%) 
Diarrhoea  1  3/791 (0.38%)  2/394 (0.51%)  0/67 (0.00%) 
Dysphagia  1  1/791 (0.13%)  2/394 (0.51%)  0/67 (0.00%) 
Enteritis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Faecaloma  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Gastritis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Haematemesis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Ileus  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Melaena  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Nausea  1  8/791 (1.01%)  3/394 (0.76%)  0/67 (0.00%) 
Oesophagitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Subileus  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Vomiting  1  17/791 (2.15%)  9/394 (2.28%)  1/67 (1.49%) 
Abdominal pain  1  6/791 (0.76%)  3/394 (0.76%)  0/67 (0.00%) 
Anal fistula  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Colitis ischaemic  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Colonic obstruction  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Diverticular perforation  1  1/791 (0.13%)  0/394 (0.00%)  1/67 (1.49%) 
Gastrointestinal haemorrhage  1  4/791 (0.51%)  0/394 (0.00%)  0/67 (0.00%) 
Gastrointestinal obstruction  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Gastrooesophageal reflux disease  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Haemorrhoids  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Inguinal hernia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Intestinal obstruction  1  1/791 (0.13%)  2/394 (0.51%)  1/67 (1.49%) 
Intestinal perforation  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pancreatitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pancreatitis acute  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Rectal haemorrhage  1  3/791 (0.38%)  3/394 (0.76%)  0/67 (0.00%) 
Small intestinal perforation  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
General disorders       
Malaise  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pain  1  1/791 (0.13%)  6/394 (1.52%)  0/67 (0.00%) 
Pyrexia  1  6/791 (0.76%)  9/394 (2.28%)  3/67 (4.48%) 
Asthenia  1  9/791 (1.14%)  1/394 (0.25%)  0/67 (0.00%) 
Catheter related complication  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Chest pain  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Disease progression  1  12/791 (1.52%)  2/394 (0.51%)  2/67 (2.99%) 
Fatigue  1  9/791 (1.14%)  6/394 (1.52%)  1/67 (1.49%) 
General physical health deterioration  1  5/791 (0.63%)  2/394 (0.51%)  0/67 (0.00%) 
Generalised oedema  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Hernia obstructive  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Injection site haemorrhage  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Localised oedema  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Non-cardiac chest pain  1  1/791 (0.13%)  2/394 (0.51%)  0/67 (0.00%) 
Oedema peripheral  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Performance status decreased  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Hepatitis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Hepatotoxicity  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Hyperbilirubinaemia  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Bile duct obstruction  1  2/791 (0.25%)  1/394 (0.25%)  0/67 (0.00%) 
Cholecystitis acute  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Cholecystitis chronic  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Infections and infestations       
Bronchitis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Cellulitis  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Cystitis  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Diverticulitis  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Gastroenteritis  1  5/791 (0.63%)  0/394 (0.00%)  1/67 (1.49%) 
Infection  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Meningitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Parotitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pneumonia  1  21/791 (2.65%)  5/394 (1.27%)  3/67 (4.48%) 
Pyelonephritis  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Sepsis  1  14/791 (1.77%)  2/394 (0.51%)  1/67 (1.49%) 
Sinusitis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Urosepsis  1  4/791 (0.51%)  1/394 (0.25%)  0/67 (0.00%) 
Abscess jaw  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Arthritis infective  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Bacterial sepsis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Bronchopneumonia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Candida sepsis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Catheter sepsis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Central line infection  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Enterocolitis infectious  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Escherichia infection  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Escherichia sepsis  1  1/791 (0.13%)  0/394 (0.00%)  1/67 (1.49%) 
Escherichia urinary tract infection  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Genitourinary tract infection  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Groin infection  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Herpes zoster  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Influenza  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Kidney infection  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Lobar pneumonia  1  0/791 (0.00%)  3/394 (0.76%)  0/67 (0.00%) 
Localised infection  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Lower respiratory tract infection  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Lung infection  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Osteomyelitis  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Pelvic abscess  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pneumonia escherichia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Post procedural infection  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Pyelonephritis acute  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Respiratory tract infection  1  1/791 (0.13%)  2/394 (0.51%)  0/67 (0.00%) 
Staphylococcal infection  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Tooth infection  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Urinary tract infection  1  19/791 (2.40%)  3/394 (0.76%)  3/67 (4.48%) 
Wound infection  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Accidental overdose  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Ankle fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cervical vertebral fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Concussion  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cystitis radiation  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Dislocation of joint prosthesis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Drug toxicity  1  0/791 (0.00%)  2/394 (0.51%)  0/67 (0.00%) 
Femur fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Foot fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Gastroenteritis radiation  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Head injury  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Hip fracture  1  5/791 (0.63%)  0/394 (0.00%)  0/67 (0.00%) 
Humerus fracture  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Incisional hernia  1  0/791 (0.00%)  0/394 (0.00%)  1/67 (1.49%) 
Joint dislocation  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Lumbar vertebral fracture  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Medical device complication  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pathological fracture  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Radiation associated pain  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Radius fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Rib fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Spinal compression fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Spinal cord injury  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Spinal fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Stent occlusion  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Subdural haematoma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Tibia fracture  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Traumatic haematoma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Upper limb fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Urostomy complication  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  3/791 (0.38%)  1/394 (0.25%)  0/67 (0.00%) 
Aspartate aminotransferase increased  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Blood alkaline phosphatase increased  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Blood creatinine increased  1  4/791 (0.51%)  2/394 (0.51%)  0/67 (0.00%) 
Blood phosphorus decreased  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Electrocardiogram QT prolonged  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Heart rate increased  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
International normalised ratio increased  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Liver function test abnormal  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Platelet count decreased  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Metabolism and nutrition disorders       
Alkalosis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Anorexia  1  4/791 (0.51%)  2/394 (0.51%)  0/67 (0.00%) 
Dehydration  1  14/791 (1.77%)  4/394 (1.02%)  1/67 (1.49%) 
Gout  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Hyperglycaemia  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Hyperuricaemia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Hypocalcaemia  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Hypoglycaemia  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Hypokalaemia  1  7/791 (0.88%)  0/394 (0.00%)  1/67 (1.49%) 
Hyponatraemia  1  4/791 (0.51%)  1/394 (0.25%)  0/67 (0.00%) 
Hypophosphataemia  1  2/791 (0.25%)  2/394 (0.51%)  0/67 (0.00%) 
Diabetes mellitus  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Failure to thrive  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Hyperkalaemia  1  1/791 (0.13%)  0/394 (0.00%)  1/67 (1.49%) 
Hypomagnesaemia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/791 (0.38%)  4/394 (1.02%)  0/67 (0.00%) 
Bursitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Coccydynia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Myopathy  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Osteoarthritis  1  2/791 (0.25%)  1/394 (0.25%)  0/67 (0.00%) 
Osteonecrosis  1  2/791 (0.25%)  0/394 (0.00%)  2/67 (2.99%) 
Back pain  1  12/791 (1.52%)  11/394 (2.79%)  4/67 (5.97%) 
Bone lesion  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Bone pain  1  16/791 (2.02%)  13/394 (3.30%)  1/67 (1.49%) 
Flank pain  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Groin pain  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Intervertebral disc protrusion  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Mobility decreased  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Muscular weakness  1  4/791 (0.51%)  1/394 (0.25%)  0/67 (0.00%) 
Musculoskeletal chest pain  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Musculoskeletal pain  1  3/791 (0.38%)  1/394 (0.25%)  0/67 (0.00%) 
Neck pain  1  3/791 (0.38%)  1/394 (0.25%)  1/67 (1.49%) 
Osteoporotic fracture  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Pain in extremity  1  4/791 (0.51%)  7/394 (1.78%)  2/67 (2.99%) 
Pathological fracture  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Spinal column stenosis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Spinal disorder  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Synovial cyst  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cancer pain  1  3/791 (0.38%)  1/394 (0.25%)  0/67 (0.00%) 
Chronic lymphocytic leukaemia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Colon cancer  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Gastric cancer  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Malignant melanoma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Malignant pleural effusion  1  1/791 (0.13%)  0/394 (0.00%)  1/67 (1.49%) 
Metastases to bone  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Metastases to central nervous system  1  4/791 (0.51%)  1/394 (0.25%)  0/67 (0.00%) 
Metastases to liver  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Metastases to lung  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Metastases to meninges  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Metastases to soft tissue  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Metastases to spine  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Metastatic pain  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Myelodysplastic syndrome  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Tumour pain  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Nervous system disorders       
Convulsion  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Dizziness  1  3/791 (0.38%)  1/394 (0.25%)  0/67 (0.00%) 
Encephalopathy  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Epiduritis  1  0/791 (0.00%)  2/394 (0.51%)  0/67 (0.00%) 
Headache  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Hemiparesis  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Neuralgia  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Paraplegia  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Syncope  1  3/791 (0.38%)  2/394 (0.51%)  0/67 (0.00%) 
Brachial plexopathy  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Brain compression  1  0/791 (0.00%)  2/394 (0.51%)  0/67 (0.00%) 
Brain oedema  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Bulbar palsy  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Cauda equina syndrome  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Cerebral haemorrhage  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cerebral ischaemia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cerebrovascular accident  1  4/791 (0.51%)  0/394 (0.00%)  0/67 (0.00%) 
Cervical cord compression  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Cranial neuropathy  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Facial paresis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Hydrocephalus  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Loss of consciousness  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Lumbar radiculopathy  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Nerve root compression  1  1/791 (0.13%)  1/394 (0.25%)  0/67 (0.00%) 
Nerve root lesion  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Neurological symptom  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Neuropathy peripheral  1  1/791 (0.13%)  2/394 (0.51%)  0/67 (0.00%) 
Peroneal nerve palsy  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Polyneuropathy  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Radiculopathy  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Spinal cord compression  1  23/791 (2.91%)  18/394 (4.57%)  3/67 (4.48%) 
Subdural hygroma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Syncope vasovagal  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Transient ischaemic attack  1  4/791 (0.51%)  2/394 (0.51%)  0/67 (0.00%) 
VIth nerve paralysis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Psychiatric disorders       
Delirium  1  1/791 (0.13%)  0/394 (0.00%)  1/67 (1.49%) 
Depression  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Confusional state  1  4/791 (0.51%)  3/394 (0.76%)  0/67 (0.00%) 
Mental status changes  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Renal and urinary disorders       
Anuria  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Dysuria  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Haematuria  1  12/791 (1.52%)  11/394 (2.79%)  0/67 (0.00%) 
Hydronephrosis  1  12/791 (1.52%)  3/394 (0.76%)  2/67 (2.99%) 
Polyuria  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Bladder stenosis  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Bladder tamponade  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Calculus ureteric  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Haemorrhage urinary tract  1  3/791 (0.38%)  1/394 (0.25%)  0/67 (0.00%) 
Nephrolithiasis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Obstructive uropathy  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pollakiuria  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Renal failure  1  4/791 (0.51%)  2/394 (0.51%)  0/67 (0.00%) 
Renal failure acute  1  7/791 (0.88%)  5/394 (1.27%)  2/67 (2.99%) 
Renal impairment  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Stress urinary incontinence  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Ureteric obstruction  1  3/791 (0.38%)  1/394 (0.25%)  1/67 (1.49%) 
Urinary hesitation  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Urinary incontinence  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Urinary retention  1  9/791 (1.14%)  6/394 (1.52%)  0/67 (0.00%) 
Urinary tract obstruction  1  0/791 (0.00%)  2/394 (0.51%)  0/67 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Oedema genital  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Pelvic haematoma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pelvic pain  1  2/791 (0.25%)  2/394 (0.51%)  0/67 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Dyspnoea  1  11/791 (1.39%)  4/394 (1.02%)  1/67 (1.49%) 
Pneumothorax  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Acute respiratory distress syndrome  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Acute respiratory failure  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Bronchial obstruction  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Chronic obstructive pulmonary disease  1  1/791 (0.13%)  0/394 (0.00%)  1/67 (1.49%) 
Epistaxis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Hypoxia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pleural effusion  1  2/791 (0.25%)  0/394 (0.00%)  2/67 (2.99%) 
Pleuritic pain  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pneumonia aspiration  1  0/791 (0.00%)  2/394 (0.51%)  0/67 (0.00%) 
Pulmonary embolism  1  7/791 (0.88%)  10/394 (2.54%)  2/67 (2.99%) 
Pulmonary oedema  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Respiratory distress  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Respiratory failure  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Skin and subcutaneous tissue disorders       
Purpura  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Erythema  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Leukocytoclastic vasculitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Skin ulcer  1  2/791 (0.25%)  0/394 (0.00%)  0/67 (0.00%) 
Surgical and medical procedures       
Eye muscle recession  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Malignant tumour excision  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Pain management  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Ureteral stent insertion  1  0/791 (0.00%)  1/394 (0.25%)  0/67 (0.00%) 
Vascular disorders       
Hypertension  1  3/791 (0.38%)  0/394 (0.00%)  0/67 (0.00%) 
Hypotension  1  4/791 (0.51%)  1/394 (0.25%)  1/67 (1.49%) 
Cardiovascular insufficiency  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Deep vein thrombosis  1  5/791 (0.63%)  1/394 (0.25%)  0/67 (0.00%) 
Embolism  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Hot flush  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Peripheral ischaemia  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Phlebitis  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Superior vena caval occlusion  1  1/791 (0.13%)  0/394 (0.00%)  0/67 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abiraterone Acetate Placebo Placebo to Abiraterone Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   766/791 (96.84%)   381/394 (96.70%)   57/67 (85.07%) 
Blood and lymphatic system disorders       
Anaemia  1  202/791 (25.54%)  105/394 (26.65%)  11/67 (16.42%) 
Gastrointestinal disorders       
Constipation  1  236/791 (29.84%)  124/394 (31.47%)  14/67 (20.90%) 
Diarrhoea  1  166/791 (20.99%)  57/394 (14.47%)  13/67 (19.40%) 
Dyspepsia  1  54/791 (6.83%)  15/394 (3.81%)  4/67 (5.97%) 
Nausea  1  272/791 (34.39%)  132/394 (33.50%)  19/67 (28.36%) 
Vomiting  1  204/791 (25.79%)  97/394 (24.62%)  14/67 (20.90%) 
Abdominal pain  1  111/791 (14.03%)  45/394 (11.42%)  4/67 (5.97%) 
Dry mouth  1  61/791 (7.71%)  20/394 (5.08%)  4/67 (5.97%) 
General disorders       
Pyrexia  1  87/791 (11.00%)  28/394 (7.11%)  7/67 (10.45%) 
Asthenia  1  131/791 (16.56%)  54/394 (13.71%)  5/67 (7.46%) 
Fatigue  1  384/791 (48.55%)  172/394 (43.65%)  19/67 (28.36%) 
Oedema peripheral  1  228/791 (28.82%)  75/394 (19.04%)  11/67 (16.42%) 
Pain  1  40/791 (5.06%)  15/394 (3.81%)  2/67 (2.99%) 
Infections and infestations       
Nasopharyngitis  1  58/791 (7.33%)  25/394 (6.35%)  6/67 (8.96%) 
Upper respiratory tract infection  1  57/791 (7.21%)  11/394 (2.79%)  2/67 (2.99%) 
Urinary tract infection  1  100/791 (12.64%)  27/394 (6.85%)  6/67 (8.96%) 
Injury, poisoning and procedural complications       
Contusion  1  70/791 (8.85%)  22/394 (5.58%)  3/67 (4.48%) 
Investigations       
Weight decreased  1  110/791 (13.91%)  57/394 (14.47%)  4/67 (5.97%) 
Metabolism and nutrition disorders       
Anorexia  1  155/791 (19.60%)  74/394 (18.78%)  4/67 (5.97%) 
Hyperglycaemia  1  61/791 (7.71%)  20/394 (5.08%)  2/67 (2.99%) 
Hypokalaemia  1  149/791 (18.84%)  36/394 (9.14%)  10/67 (14.93%) 
Decreased appetite  1  89/791 (11.25%)  36/394 (9.14%)  4/67 (5.97%) 
Dehydration  1  43/791 (5.44%)  18/394 (4.57%)  2/67 (2.99%) 
Hypomagnesaemia  1  9/791 (1.14%)  3/394 (0.76%)  4/67 (5.97%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  246/791 (31.10%)  93/394 (23.60%)  20/67 (29.85%) 
Back pain  1  282/791 (35.65%)  138/394 (35.03%)  23/67 (34.33%) 
Bone pain  1  219/791 (27.69%)  112/394 (28.43%)  12/67 (17.91%) 
Groin pain  1  51/791 (6.45%)  22/394 (5.58%)  5/67 (7.46%) 
Muscle spasms  1  79/791 (9.99%)  37/394 (9.39%)  4/67 (5.97%) 
Muscular weakness  1  94/791 (11.88%)  38/394 (9.64%)  8/67 (11.94%) 
Musculoskeletal pain  1  140/791 (17.70%)  56/394 (14.21%)  12/67 (17.91%) 
Myalgia  1  50/791 (6.32%)  17/394 (4.31%)  6/67 (8.96%) 
Neck pain  1  35/791 (4.42%)  20/394 (5.08%)  4/67 (5.97%) 
Pain in extremity  1  170/791 (21.49%)  81/394 (20.56%)  13/67 (19.40%) 
Nervous system disorders       
Dizziness  1  99/791 (12.52%)  40/394 (10.15%)  2/67 (2.99%) 
Headache  1  111/791 (14.03%)  42/394 (10.66%)  6/67 (8.96%) 
Hypoaesthesia  1  41/791 (5.18%)  15/394 (3.81%)  2/67 (2.99%) 
Paraesthesia  1  41/791 (5.18%)  15/394 (3.81%)  3/67 (4.48%) 
Psychiatric disorders       
Anxiety  1  55/791 (6.95%)  21/394 (5.33%)  2/67 (2.99%) 
Depression  1  47/791 (5.94%)  21/394 (5.33%)  2/67 (2.99%) 
Insomnia  1  98/791 (12.39%)  52/394 (13.20%)  5/67 (7.46%) 
Renal and urinary disorders       
Haematuria  1  76/791 (9.61%)  27/394 (6.85%)  2/67 (2.99%) 
Nocturia  1  54/791 (6.83%)  17/394 (4.31%)  4/67 (5.97%) 
Pollakiuria  1  61/791 (7.71%)  21/394 (5.33%)  4/67 (5.97%) 
Urinary incontinence  1  42/791 (5.31%)  15/394 (3.81%)  4/67 (5.97%) 
Reproductive system and breast disorders       
Pelvic pain  1  20/791 (2.53%)  20/394 (5.08%)  2/67 (2.99%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  116/791 (14.66%)  33/394 (8.38%)  7/67 (10.45%) 
Dyspnoea  1  117/791 (14.79%)  49/394 (12.44%)  10/67 (14.93%) 
Skin and subcutaneous tissue disorders       
Ecchymosis  1  17/791 (2.15%)  12/394 (3.05%)  4/67 (5.97%) 
Hyperhidrosis  1  44/791 (5.56%)  16/394 (4.06%)  1/67 (1.49%) 
Vascular disorders       
Hypertension  1  79/791 (9.99%)  27/394 (6.85%)  5/67 (7.46%) 
Hot flush  1  157/791 (19.85%)  68/394 (17.26%)  2/67 (2.99%) 
Hypotension  1  35/791 (4.42%)  18/394 (4.57%)  4/67 (5.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 60 days from the time submitted to the sponsor for review. After 1) publication of multi-center results, 2) notification by sponsor that a multi-center submission is no longer planned, or 3) the 18 month anniversary of the termination of the study at all sites, the institution and investigator may publish or publicly present study data.
Results Point of Contact
Name/Title: Senior Director, Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development
Phone: 310-914-2915
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00638690     History of Changes
Other Study ID Numbers: CR016924
COU-AA-301 ( Other Identifier: Cougar Biotechnology, Inc )
First Submitted: March 13, 2008
First Posted: March 19, 2008
Results First Submitted: August 23, 2011
Results First Posted: May 16, 2013
Last Update Posted: April 30, 2014