Trial Outcomes & Findings for IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen (NCT NCT01314118)
NCT ID: NCT01314118
Last Updated: 2025-12-12
Results Overview
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
End of core study visit (Approximately at Month 6)
Results posted on
2025-12-12
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate Plus Prednisone
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
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Overall Study
STARTED
|
131
|
|
Overall Study
Completed Until Treatment Cycle 6
|
112
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
84
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate Plus Prednisone
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
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Overall Study
Adverse Event
|
10
|
|
Overall Study
Progressive disease
|
3
|
|
Overall Study
Death
|
8
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Sponsor Decision
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
26
|
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Overall Study
Other
|
21
|
Baseline Characteristics
IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate Plus Prednisone
n=131 Participants
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
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Age, Continuous
|
71.2 Years
STANDARD_DEVIATION 8.82 • n=26 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
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108 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
122 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=26 Participants
|
|
Region of Enrollment
United States
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131 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: End of core study visit (Approximately at Month 6)Population: Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Outcome measures
| Measure |
Abiraterone Acetate Plus Prednisone
n=122 Participants
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
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86.9 Percentage of participants
Interval 80.9 to 92.9
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SECONDARY outcome
Timeframe: Maximum up to Month 30.5Population: All enrolled set included all participants who received at least 1 dose of study drug.
Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (\>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If \>=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.
Outcome measures
| Measure |
Abiraterone Acetate Plus Prednisone
n=131 Participants
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
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Time to Radiographic Evidence of Disease Progression (TTRP)
|
41.4 Months
Interval 27.6 to
Data was not evaluable as insufficient number of participants had the event.
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SECONDARY outcome
Timeframe: Maximum up to Month 30.5Population: All enrolled set included all participants who received at least 1 dose of study drug.
Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.
Outcome measures
| Measure |
Abiraterone Acetate Plus Prednisone
n=131 Participants
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
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Time to Prostate-Specific Antigen (PSA) Progression
|
28.7 Months
Interval 21.2 to 38.2
|
SECONDARY outcome
Timeframe: End of Cycle 3 (Approximately Month 3)Population: Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.
Outcome measures
| Measure |
Abiraterone Acetate Plus Prednisone
n=122 Participants
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
|
85.2 Percentage of Participants
Interval 79.0 to 91.5
|
Adverse Events
Abiraterone Acetate Plus Prednisone
Serious events: 61 serious events
Other events: 120 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Abiraterone Acetate Plus Prednisone
n=131 participants at risk
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
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|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Arrhythmia
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Atrial Fibrillation
|
2.3%
3/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Bradycardia
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Cardiac Failure
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Coronary Artery Disease
|
3.1%
4/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Cardiac disorders
Tachycardia
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Endocrine disorders
Adrenal Mass
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Diverticulum
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Rectourethral Fistula
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Asthenia
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Chest Pain
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Oedema Peripheral
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Appendicitis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Chest Wall Abscess
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Giardiasis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Lobar Pneumonia
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Lung Infection
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Osteomyelitis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Pneumonia
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Postoperative Wound Infection
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Sepsis
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Septic Shock
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
4/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Urosepsis
|
3.8%
5/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Cystitis Radiation
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
3/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Transplant Failure
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Alanine Aminotransferase Increased
|
3.1%
4/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Blood Glucose Increased
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Blood Potassium Increased
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Hepatic Enzyme Increased
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Liver Function Test Abnormal
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
3/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Balance Disorder
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Brain Mass
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Dementia
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Dizziness
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Neurological Symptom
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Presyncope
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Syncope
|
3.8%
5/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Psychiatric disorders
Acute Psychosis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Haematuria
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Hydronephrosis
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Urinary Retention
|
3.8%
5/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Surgical and medical procedures
Nephrectomy
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Surgical and medical procedures
Transurethral Prostatectomy
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Arteriosclerosis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Embolism
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Hypertension
|
1.5%
2/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Hypertensive Crisis
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Hypotension
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Peripheral Circulatory Failure
|
0.76%
1/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
Other adverse events
| Measure |
Abiraterone Acetate Plus Prednisone
n=131 participants at risk
Participants were given abiraterone acetate 1000 milligrams (mg) (4\*250 mg) tablets plus prednisone 5 mg (2\*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
19.1%
25/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.6%
27/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Nausea
|
20.6%
27/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
21/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Asthenia
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Chest Pain
|
6.9%
9/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Fatigue
|
42.7%
56/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Influenza Like Illness
|
8.4%
11/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Oedema Peripheral
|
26.0%
34/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
General disorders
Pyrexia
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Bronchitis
|
7.6%
10/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Influenza
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
18/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Sinusitis
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.8%
22/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Infections and infestations
Urinary Tract Infection
|
18.3%
24/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Fall
|
12.2%
16/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Alanine Aminotransferase Increased
|
6.9%
9/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.9%
9/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Blood Creatinine Increased
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Investigations
Weight Decreased
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.6%
44/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.3%
24/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.6%
23/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
8.4%
11/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.4%
11/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
13.7%
18/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Dizziness
|
20.6%
27/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Headache
|
19.1%
25/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Nervous system disorders
Paraesthesia
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Psychiatric disorders
Anxiety
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Psychiatric disorders
Depression
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Psychiatric disorders
Insomnia
|
7.6%
10/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Dysuria
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Haematuria
|
16.0%
21/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Micturition Urgency
|
7.6%
10/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Nocturia
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Pollakiuria
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Urinary Incontinence
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Renal and urinary disorders
Urinary Retention
|
14.5%
19/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Blood and lymphatic system disorders
Anaemia
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Eye disorders
Cataract
|
6.9%
9/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
25/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.9%
13/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.4%
11/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.3%
7/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
8/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Hot Flush
|
10.7%
14/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
|
Vascular disorders
Hypertension
|
44.3%
58/131 • All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
- Publication restrictions are in place
Restriction type: OTHER