Trial Outcomes & Findings for Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy (NCT NCT00638690)

NCT ID: NCT00638690

Last Updated: 2014-04-30

Results Overview

Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1195 participants

Primary outcome timeframe

Up to 60 months

Results posted on

2014-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Abiraterone Acetate 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 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 Study STARTED	797	398
Overall Study COMPLETED	116	56
Overall Study NOT COMPLETED	681	342

Reasons for withdrawal

Reasons for withdrawal
Measure	Abiraterone Acetate 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 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 Study Death	655	335
Overall Study Withdrawal by Subject	22	5
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abiraterone Acetate n=797 Participants 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 n=398 Participants Placebo plus prednisone/prednisolone	Total n=1195 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 8.4 • n=5 Participants	68.9 years STANDARD_DEVIATION 8.61 • n=7 Participants	69 years STANDARD_DEVIATION 8.46 • 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	797 Participants n=5 Participants	398 Participants n=7 Participants	1195 Participants n=5 Participants
Region of Enrollment Australia	69 participants n=5 Participants	35 participants n=7 Participants	104 participants n=5 Participants
Region of Enrollment Austria	11 participants n=5 Participants	1 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Belgium	32 participants n=5 Participants	11 participants n=7 Participants	43 participants n=5 Participants
Region of Enrollment Canada	97 participants n=5 Participants	57 participants n=7 Participants	154 participants n=5 Participants
Region of Enrollment France	57 participants n=5 Participants	33 participants n=7 Participants	90 participants n=5 Participants
Region of Enrollment Germany	26 participants n=5 Participants	12 participants n=7 Participants	38 participants n=5 Participants
Region of Enrollment Hungary	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Italy	21 participants n=5 Participants	12 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Republic of Ireland	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Spain	13 participants n=5 Participants	3 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment United Kingdom	119 participants n=5 Participants	61 participants n=7 Participants	180 participants n=5 Participants
Region of Enrollment United States	336 participants n=5 Participants	162 participants n=7 Participants	498 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 months

Population: 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.

Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=797 Participants 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 n=398 Participants 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 Survival	450.0 Days Interval 430.0 to 470.0	332.0 Days Interval 310.0 to 366.0

SECONDARY outcome

Timeframe: Up to 12 months

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.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=797 Participants 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 n=398 Participants Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria	309.0 Days Interval 255.0 to 421.0	200.0 Days Interval 170.0 to 254.0

SECONDARY outcome

Timeframe: Up to 12 months

A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=797 Participants 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 n=398 Participants Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%	232 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to 11 months

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.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=797 Participants 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 n=398 Participants Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
Radiographic Progression-free Survival	171.0 Days Interval 169.0 to 192.0	110.0 Days Interval 88.0 to 168.0

Adverse Events

Abiraterone Acetate

Serious events: 365 serious events

Other events: 766 other events

Deaths: 0 deaths

Placebo

Serious events: 175 serious events

Other events: 381 other events

Deaths: 0 deaths

Placebo to Abiraterone Acetate

Serious events: 29 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Director, Clinical Research

Johnson & Johnson Pharmaceutical Research & Development

Phone: 310-914-2915

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Abiraterone Acetate n=791 participants at risk 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 n=394 participants at risk Placebo plus prednisone/prednisolone	Placebo to Abiraterone Acetate n=67 participants at risk Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
Infections and infestations Genitourinary tract infection	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Infections and infestations Groin infection	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Blood and lymphatic system disorders Anaemia	3.3% 26/791 • 5 years 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.	3.8% 15/394 • 5 years 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.	1.5% 1/67 • 5 years 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.
Blood and lymphatic system disorders Coagulopathy	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Blood and lymphatic system disorders Pancytopenia	0.13% 1/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Blood and lymphatic system disorders Thrombocytopenia	0.76% 6/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Cardiac disorders Bradycardia	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Ear and labyrinth disorders Hypoacusis	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Ear and labyrinth disorders Tinnitus	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Ear and labyrinth disorders Vertigo	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Endocrine disorders Hyperglycaemia	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Eye disorders Blindness	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Eye disorders Cataract	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Eye disorders Diplopia	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Eye disorders Keratitis	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Constipation	0.63% 5/791 • 5 years 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.	0.76% 3/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Diarrhoea	0.38% 3/791 • 5 years 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.	0.51% 2/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Dysphagia	0.13% 1/791 • 5 years 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.	0.51% 2/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Enteritis	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Faecaloma	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Gastritis	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Haematemesis	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Ileus	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Melaena	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Nausea	1.0% 8/791 • 5 years 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.	0.76% 3/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Oesophagitis	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Subileus	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Gastrointestinal disorders Vomiting	2.1% 17/791 • 5 years 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.	2.3% 9/394 • 5 years 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.	1.5% 1/67 • 5 years 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.
General disorders Malaise	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
General disorders Pain	0.13% 1/791 • 5 years 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.	1.5% 6/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
General disorders Pyrexia	0.76% 6/791 • 5 years 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.	2.3% 9/394 • 5 years 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.	4.5% 3/67 • 5 years 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.
Hepatobiliary disorders Cholecystitis	0.13% 1/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Hepatobiliary disorders Hepatitis	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Hepatobiliary disorders Hepatotoxicity	0.13% 1/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Hepatobiliary disorders Hyperbilirubinaemia	0.13% 1/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Infections and infestations Bronchitis	0.00% 0/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Infections and infestations Cellulitis	0.13% 1/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Infections and infestations Cystitis	0.13% 1/791 • 5 years 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.	0.25% 1/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Infections and infestations Diverticulitis	0.25% 2/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	0.00% 0/67 • 5 years 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.
Infections and infestations Gastroenteritis	0.63% 5/791 • 5 years 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.	0.00% 0/394 • 5 years 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.	1.5% 1/67 • 5 years 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.

Other adverse events
Measure	Abiraterone Acetate n=791 participants at risk 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 n=394 participants at risk Placebo plus prednisone/prednisolone	Placebo to Abiraterone Acetate n=67 participants at risk Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
Blood and lymphatic system disorders Anaemia	25.5% 202/791 • 5 years 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.	26.6% 105/394 • 5 years 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.	16.4% 11/67 • 5 years 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.
Gastrointestinal disorders Constipation	29.8% 236/791 • 5 years 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.	31.5% 124/394 • 5 years 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.	20.9% 14/67 • 5 years 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.
Gastrointestinal disorders Diarrhoea	21.0% 166/791 • 5 years 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.	14.5% 57/394 • 5 years 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.	19.4% 13/67 • 5 years 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.
Gastrointestinal disorders Dyspepsia	6.8% 54/791 • 5 years 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.	3.8% 15/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Gastrointestinal disorders Nausea	34.4% 272/791 • 5 years 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.	33.5% 132/394 • 5 years 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.	28.4% 19/67 • 5 years 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.
Gastrointestinal disorders Vomiting	25.8% 204/791 • 5 years 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.	24.6% 97/394 • 5 years 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.	20.9% 14/67 • 5 years 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.
General disorders Pyrexia	11.0% 87/791 • 5 years 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.	7.1% 28/394 • 5 years 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.	10.4% 7/67 • 5 years 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.
Infections and infestations Nasopharyngitis	7.3% 58/791 • 5 years 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.	6.3% 25/394 • 5 years 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.	9.0% 6/67 • 5 years 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.
Injury, poisoning and procedural complications Contusion	8.8% 70/791 • 5 years 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.	5.6% 22/394 • 5 years 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.	4.5% 3/67 • 5 years 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.
Metabolism and nutrition disorders Anorexia	19.6% 155/791 • 5 years 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.	18.8% 74/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 61/791 • 5 years 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.	5.1% 20/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Metabolism and nutrition disorders Hypokalaemia	18.8% 149/791 • 5 years 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.	9.1% 36/394 • 5 years 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.	14.9% 10/67 • 5 years 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.
Musculoskeletal and connective tissue disorders Arthralgia	31.1% 246/791 • 5 years 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.	23.6% 93/394 • 5 years 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.	29.9% 20/67 • 5 years 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.
Nervous system disorders Dizziness	12.5% 99/791 • 5 years 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.	10.2% 40/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Nervous system disorders Headache	14.0% 111/791 • 5 years 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.	10.7% 42/394 • 5 years 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.	9.0% 6/67 • 5 years 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.
Psychiatric disorders Anxiety	7.0% 55/791 • 5 years 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.	5.3% 21/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Psychiatric disorders Depression	5.9% 47/791 • 5 years 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.	5.3% 21/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Psychiatric disorders Insomnia	12.4% 98/791 • 5 years 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.	13.2% 52/394 • 5 years 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.	7.5% 5/67 • 5 years 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.
Renal and urinary disorders Haematuria	9.6% 76/791 • 5 years 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.	6.9% 27/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Renal and urinary disorders Nocturia	6.8% 54/791 • 5 years 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.	4.3% 17/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Renal and urinary disorders Pollakiuria	7.7% 61/791 • 5 years 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.	5.3% 21/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Respiratory, thoracic and mediastinal disorders Cough	14.7% 116/791 • 5 years 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.	8.4% 33/394 • 5 years 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.	10.4% 7/67 • 5 years 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.8% 117/791 • 5 years 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.	12.4% 49/394 • 5 years 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.	14.9% 10/67 • 5 years 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.
Vascular disorders Hypertension	10.0% 79/791 • 5 years 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.	6.9% 27/394 • 5 years 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.	7.5% 5/67 • 5 years 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.
Gastrointestinal disorders Abdominal pain	14.0% 111/791 • 5 years 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.	11.4% 45/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Gastrointestinal disorders Dry mouth	7.7% 61/791 • 5 years 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.	5.1% 20/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
General disorders Asthenia	16.6% 131/791 • 5 years 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.	13.7% 54/394 • 5 years 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.	7.5% 5/67 • 5 years 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.
General disorders Fatigue	48.5% 384/791 • 5 years 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.	43.7% 172/394 • 5 years 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.	28.4% 19/67 • 5 years 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.
General disorders Oedema peripheral	28.8% 228/791 • 5 years 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.	19.0% 75/394 • 5 years 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.	16.4% 11/67 • 5 years 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.
General disorders Pain	5.1% 40/791 • 5 years 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.	3.8% 15/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Infections and infestations Upper respiratory tract infection	7.2% 57/791 • 5 years 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.	2.8% 11/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Infections and infestations Urinary tract infection	12.6% 100/791 • 5 years 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.	6.9% 27/394 • 5 years 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.	9.0% 6/67 • 5 years 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.
Investigations Weight decreased	13.9% 110/791 • 5 years 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.	14.5% 57/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Metabolism and nutrition disorders Decreased appetite	11.3% 89/791 • 5 years 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.	9.1% 36/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Metabolism and nutrition disorders Dehydration	5.4% 43/791 • 5 years 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.	4.6% 18/394 • 5 years 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.	3.0% 2/67 • 5 years 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.
Metabolism and nutrition disorders Hypomagnesaemia	1.1% 9/791 • 5 years 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.	0.76% 3/394 • 5 years 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.	6.0% 4/67 • 5 years 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.
Musculoskeletal and connective tissue disorders Back pain	35.7% 282/791 • 5 years 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.	35.0% 138/394 • 5 years 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.	34.3% 23/67 • 5 years 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.
Musculoskeletal and connective tissue disorders Bone pain	27.7% 219/791 • 5 years 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.	28.4% 112/394 • 5 years 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.	17.9% 12/67 • 5 years 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.
Musculoskeletal and connective tissue disorders Groin pain	6.4% 51/791 • 5 years 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.	5.6% 22/394 • 5 years 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.	7.5% 5/67 • 5 years 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.
Musculoskeletal and connective tissue disorders Muscle spasms	10.0% 79/791 • 5 years 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.	9.4% 37/394 • 5 years 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.	6.0% 4/67 • 5 years 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.