Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

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

Time frame: From randomization (Day 1) up to end of study (Month 60)

Population: Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.

Time frame: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Time frame: Up to Cycle 5, Day 1

Population: Data was not reported as non-compartmental analysis was not performed due to sparse sampling.

The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Time frame: Up to Cycle 5, Day 1

Population: Data was not reported as non-compartmental analysis was not performed due to sparse sampling.

Time frame: Up to Cycle 5, Day 1

Population: Data was not reported as non-compartmental analysis was not performed due to sparse sampling.

Time frame: Up to Cycle 5, Day 1

Population: Data was not reported as non-compartmental analysis was not performed due to sparse sampling.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: From first dose of study drug up to 30 days after the last dose of study drug

Population: Safety analysis set included all participants in the randomized population who received any study drug.

The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.

Time frame: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.

Time frame: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)

Population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.

Time frame: From randomization (Day 1) up to first opiate use or end of study (Month 60)

Population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.

Time frame: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

Population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.