Trial Outcomes & Findings for Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy (NCT NCT01485861)

NCT ID: NCT01485861

Last Updated: 2023-09-14

Results Overview

DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than \[\<\] 500 per microliter) lasting greater than (\>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for \> 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

298 participants

Primary outcome timeframe

Days 1 to 28 of Cycle 1 (Cycle length = 28 days)

Results posted on

2023-09-14

Participant Flow

The study was conducted at 55 centers in 10 countries.

The study consisted of 3 stages: Phase Ib determined recommended Phase II doses (RP2D) for ipatasertib and apitolisib in combination with abiraterone and prednisone/prednisolone. Phase II stage compared ipatasertib (400 mg or 200 mg daily) versus placebo each combined with abiraterone and prednisone/prednisolone. The third stage included the safety cohort.

Participant milestones

Participant milestones
Measure
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Safety Cohort: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
Phase Ib
STARTED
14
6
0
0
0
0
Phase Ib
Safety Population
14
6
0
0
0
0
Phase Ib
COMPLETED
0
0
0
0
0
0
Phase Ib
NOT COMPLETED
14
6
0
0
0
0
Phase II
STARTED
0
0
84
86
83
0
Phase II
Safety Population
0
0
84
88
81
0
Phase II
COMPLETED
0
0
1
0
0
0
Phase II
NOT COMPLETED
0
0
83
86
83
0
Safety Phase
STARTED
0
0
0
0
0
25
Safety Phase
COMPLETED
0
0
0
0
0
0
Safety Phase
NOT COMPLETED
0
0
0
0
0
25

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase Ib: Ipatasertib 400 mg
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 200 mg + Abiraterone
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Safety Cohort: Ipatasertib 400 mg + Abiraterone
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
Phase Ib
Death
1
0
0
0
0
0
Phase Ib
Physician Decision
1
1
0
0
0
0
Phase Ib
Adverse Event
0
4
0
0
0
0
Phase Ib
Progression of disease
5
0
0
0
0
0
Phase Ib
Other
3
0
0
0
0
0
Phase Ib
Withdrawal by Subject
4
1
0
0
0
0
Phase II
Death
0
0
67
71
68
0
Phase II
Progression of Disease
0
0
1
0
0
0
Phase II
Other
0
0
0
1
0
0
Phase II
Withdrawal by Subject
0
0
6
3
4
0
Phase II
Lost to Follow-up
0
0
2
3
5
0
Phase II
Study Ended
0
0
7
8
6
0
Safety Phase
Death
0
0
0
0
0
2
Safety Phase
Adverse Event
0
0
0
0
0
1
Safety Phase
Other
0
0
0
0
0
5
Safety Phase
Progression of Disease
0
0
0
0
0
9
Safety Phase
Withdrawal by Subject
0
0
0
0
0
6
Safety Phase
Discontinuation of Survival Follow-up
0
0
0
0
0
2

Baseline Characteristics

Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 400 mg + Abiraterone
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 200 mg + Abiraterone
n=86 Participants
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Safety Cohort: Ipatasertib 400 mg + Abiraterone
n=25 Participants
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
Total
n=298 Participants
Total of all reporting groups
Age, Continuous
68.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
69.3 years
STANDARD_DEVIATION 9.3 • n=7 Participants
66.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
68.8 years
STANDARD_DEVIATION 7.2 • n=4 Participants
67.6 years
STANDARD_DEVIATION 7.8 • n=21 Participants
73.7 years
STANDARD_DEVIATION 8.8 • n=8 Participants
68.3 years
STANDARD_DEVIATION 8.2 • n=8 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
6 Participants
n=7 Participants
84 Participants
n=5 Participants
86 Participants
n=4 Participants
83 Participants
n=21 Participants
25 Participants
n=8 Participants
298 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
4 Participants
n=21 Participants
1 Participants
n=8 Participants
14 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=5 Participants
6 Participants
n=7 Participants
70 Participants
n=5 Participants
63 Participants
n=4 Participants
68 Participants
n=21 Participants
24 Participants
n=8 Participants
244 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
10 Participants
n=5 Participants
18 Participants
n=4 Participants
11 Participants
n=21 Participants
0 Participants
n=8 Participants
40 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
9 Participants
n=8 Participants
Race (NIH/OMB)
White
13 Participants
n=5 Participants
5 Participants
n=7 Participants
73 Participants
n=5 Participants
75 Participants
n=4 Participants
73 Participants
n=21 Participants
24 Participants
n=8 Participants
263 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
9 Participants
n=4 Participants
9 Participants
n=21 Participants
0 Participants
n=8 Participants
23 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Days 1 to 28 of Cycle 1 (Cycle length = 28 days)

Population: The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.

DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than \[\<\] 500 per microliter) lasting greater than (\>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for \> 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
0 percentage of participants
0 percentage of participants

PRIMARY outcome

Timeframe: Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).

Population: The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.

An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Percentage of Participants With Adverse Events (AEs)
100.0 percentage of participants
100.0 percentage of participants

PRIMARY outcome

Timeframe: Days 1 to 28 of Cycle 1 (Cycle length = 28 days)

Population: The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.

RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
Apitolisib
NA milligrams (mg)
Based on safety analysis further testing of apitolisib arm was discontinued.
Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
Ipatasertib
400 milligrams (mg)

PRIMARY outcome

Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (\< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization).

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)
8.18 months
Interval 6.67 to 10.87
8.31 months
Interval 6.44 to 10.48
6.37 months
Interval 4.6 to 8.34

PRIMARY outcome

Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (\< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss
11.53 months
Interval 6.67 to 13.73
11.10 months
Interval 6.34 to 16.36
4.60 months
Interval 4.4 to 6.37

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone
Cycle 1, Day 1
269 ng/mL
Geometric Coefficient of Variation 41.3
Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone
Cycle 1, Day 15
466 ng/mL
Geometric Coefficient of Variation 36.2

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone
Cycle 1, Day 1
2.00 hours
Interval 0.97 to 4.05
Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone
Cycle 1, Day 15
2.02 hours
Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone
Cycle 1, Day 1
1710 ng/mL*hours
Geometric Coefficient of Variation 54.7
Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone
Cycle 1, Day 15
3290 ng/mL*hours
Geometric Coefficient of Variation 37.0

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone
99600 milliliter per hour (mL/h)
Geometric Coefficient of Variation 50.7

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone
1.82 ratio
Geometric Coefficient of Variation 40.9

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)
Cycle 1, Day 1
117 ng/mL
Geometric Coefficient of Variation 64.4
Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)
Cycle 1, Day 15
326 ng/mL
Geometric Coefficient of Variation 42.4

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)
Cycle 1, Day 1
2.00 hours
Interval 1.0 to 4.05
Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)
Cycle 1, Day 15
2.10 hours
Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)
Cycle 1, Day 1
839 ng/mL*hour
Geometric Coefficient of Variation 70.3
Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)
Cycle 1, Day 15
2850 ng/mL*hour
Geometric Coefficient of Variation 71.7

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)
2.79 ratio
Geometric Coefficient of Variation 54.4

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=6 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone
Cycle 1, Day 1
190 ng/mL
Geometric Coefficient of Variation 35.2
Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone
Cycle 1, Day 15
193 ng/mL
Geometric Coefficient of Variation 16.2

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=6 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone
Cycle 1, Day 1
2.02 hours
Interval 1.0 to 4.1
Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone
Cycle 1, Day 15
2.04 hours
Interval 2.0 to 2.08

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=6 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone
Cycle 1, Day 1
1600 ng/mL*hours
Geometric Coefficient of Variation 47.5
Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone
Cycle 1, Day 15
1640 ng/mL*hours
Geometric Coefficient of Variation 5.65

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 1
151 ng/mL
Geometric Coefficient of Variation 123.6
88.2 ng/mL
Geometric Coefficient of Variation 218
Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 15
140 ng/mL
Geometric Coefficient of Variation 124.4
52.7 ng/mL
Geometric Coefficient of Variation 182

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=14 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 1
2.05 hours
Interval 2.0 to 6.45
2.01 hours
Interval 1.0 to 4.03
Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 15
2.17 hours
Interval 2.0 to 6.0
3.04 hours
Interval 2.0 to 4.08

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 1
749 ng/mL*hr
Geometric Coefficient of Variation 92.0
475 ng/mL*hr
Geometric Coefficient of Variation 203.4
Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 15
961 ng/mL*hr
Geometric Coefficient of Variation 87.2
220 ng/mL*hr
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be estimated as only 1 participant was evaluated.

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=10 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=5 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 1
5.25 hours
Geometric Coefficient of Variation 13.0
7.68 hours
Geometric Coefficient of Variation 26.2
Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
Cycle 1, Day 15
6.92 hours
Geometric Coefficient of Variation 23.5
14.70 hours
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be estimated as only 1 participant was evaluated.

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.

Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=1 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
0.823 ratio
Geometric Coefficient of Variation 70.7
0.882 ratio
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be estimated as only 1 participant was evaluated.

SECONDARY outcome

Timeframe: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Overall Survival (ITT Population)
18.27 Months
Interval 16.66 to 24.21
17.31 Months
Interval 13.83 to 22.41
18.37 Months
Interval 13.8 to 20.96

SECONDARY outcome

Timeframe: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Overall Survival in Participants With ICR IHC PTEN Loss
17.12 months
Interval 12.32 to 28.02
28.45 months
Interval 13.24 to 33.28
17.28 months
Interval 11.3 to 20.96

SECONDARY outcome

Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With PSA Progression (ITT Population)
57.1 percentage of participants
69.8 percentage of participants
72.3 percentage of participants

SECONDARY outcome

Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss
72.0 percentage of participants
64.0 percentage of participants
66.7 percentage of participants

SECONDARY outcome

Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Time to PSA Progression (ITT Population)
5.55 months
90% Confidence Interval 4.17 • Interval 4.17 to 7.39
3.78 months
90% Confidence Interval 2.79 • Interval 2.79 to 5.49
3.71 months
90% Confidence Interval 2.79 • Interval 2.79 to 4.67

SECONDARY outcome

Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Time to PSA Progression in Participants With ICR PTEN Loss
3.71 Months
90% Confidence Interval 2.99 • Interval 2.99 to 8.18
2.92 Months
90% Confidence Interval 2.07 • Interval 2.07 to 7.39
2.79 Months
90% Confidence Interval 1.02 • Interval 1.02 to 4.67

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

PSA response was defined as a \> 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With PSA Response (ITT Population)
36.9 Percentage of Participants
Interval 28.11 to 46.4
33.7 Percentage of Participants
Interval 25.29 to 42.93
34.9 Percentage of Participants
Interval 26.25 to 43.75

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

PSA response was defined as a \> 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss
40.0 percentage of participants
Interval 24.57 to 58.32
44.0 percentage of participants
Interval 26.99 to 61.06
28.6 percentage of participants
Interval 13.24 to 46.41

SECONDARY outcome

Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants included in the actual analysis.

Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=37 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=39 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=35 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With Objective Response (ITT Population)
32.4 percentage of participants
90% Confidence Interval 20.56 • Interval 20.56 to 46.41
23.1 percentage of participants
90% Confidence Interval 13.69 • Interval 13.69 to 35.63
22.9 percentage of participants
90% Confidence Interval 11.91 • Interval 11.91 to 36.46

SECONDARY outcome

Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for participants included in the actual analysis.

Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=9 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=15 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=7 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss
11.1 percentage of participants
Interval 1.16 to 39.09
26.7 percentage of participants
Interval 12.18 to 50.0
14.3 percentage of participants
Interval 1.49 to 50.0

SECONDARY outcome

Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants who had achieved an objective response.

Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=9 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=8 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Duration of Tumor Response (ITT Population)
8.77 months
Interval 3.75 to
Data was not evaluable due to an insufficient number of events.
NA months
Interval 6.47 to
Data was not evaluable due to an insufficient number of events.
NA months
Interval 2.76 to
Data was not evaluable due to an insufficient number of events.

SECONDARY outcome

Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=1 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=4 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=1 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss
8.77 months
NA = Not estimable due to limited number of events observed
NA months
Interval 0.99 to
NA = Not estimable due to limited number of events observed
NA months
NA = Not estimable due to limited number of events observed

SECONDARY outcome

Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants with CTC \> 0 cells/7.5 milliliters (mL) at baseline.

CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=58 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=62 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=63 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)
67.2 percentage of participants
Interval 56.44 to 77.37
71.0 percentage of participants
Interval 61.07 to 80.32
63.5 percentage of participants
Interval 52.41 to 73.6

SECONDARY outcome

Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for PTEN loss participants with CTC \> 0 cells/7.5 milliliters (mL) at baseline.

CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=20 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=20 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=17 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss
75.0 percentage of participants
Interval 55.8 to 87.42
75.0 percentage of participants
Interval 55.8 to 87.42
70.6 percentage of participants
Interval 50.0 to 85.95

SECONDARY outcome

Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants with CTC \> 0 cells/7.5 milliliters (mL) at baseline.

CTC conversion was defined as a decline to \< 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=41 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=47 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=48 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With CTC Conversion (ITT Population)
43.9 percentage of participants
90% Confidence Interval 31.18 • Interval 31.18 to 57.87
46.8 percentage of participants
90% Confidence Interval 34.48 • Interval 34.48 to 59.72
41.7 percentage of participants
90% Confidence Interval 29.59 • Interval 29.59 to 54.55

SECONDARY outcome

Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for PTEN loss participants with CTC \> 0 cells/7.5 milliliters (mL) at baseline.

CTC conversion was defined as a decline to \< 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=12 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=18 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=22 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss
66.7 percentage of participants
Interval 39.84 to 84.58
22.2 percentage of participants
Interval 10.06 to 41.88
31.8 percentage of participants
Interval 18.11 to 50.0

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With Pain Progression (ITT Population)
33.3 percentage of participants
34.9 percentage of participants
34.9 percentage of participants

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss
40.0 percentage of participants
28.0 percentage of participants
33.3 percentage of participants

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Population: The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=83 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Time to Pain Progression (ITT Population)
13.90 months
Interval 8.61 to
Data was not evaluable because of an insufficient number of events.
16.16 months
Interval 8.54 to
Data was not evaluable because of an insufficient number of events.
15.15 months
Interval 11.07 to
Data was not evaluable because of an insufficient number of events.

SECONDARY outcome

Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Population: The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.

Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=25 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=25 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=21 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Time to Pain Progression in Participants With ICR PTEN Loss
16.49 months
Interval 7.59 to 16.49
NA months
Interval 8.28 to
Data was not evaluable because of an insufficient number of events.
6.93 months
Interval 5.65 to
Data was not evaluable because of an insufficient number of events.

SECONDARY outcome

Timeframe: Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)

Population: The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment.

An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=84 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=88 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=81 Participants
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Percentage of Participants With Adverse Events (AEs)
98.8 percentage of participants
96.6 percentage of participants
93.8 percentage of participants

SECONDARY outcome

Timeframe: Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data. Data were only analyzed in ipatasertib treatment arms. Total number analyzed represents all participants with evaluations at one or more time points.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=83 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 1, Day 1: 1 hour postdose
101 ng/mL
Geometric Coefficient of Variation 359.5
63.4 ng/mL
Geometric Coefficient of Variation 187.2
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 1, Day 1: 4 hours postdose
180 ng/mL
Geometric Coefficient of Variation 103.4
87.0 ng/mL
Geometric Coefficient of Variation 71.6
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 1, Day 15: predose
53.1 ng/mL
Geometric Coefficient of Variation 97.2
24.5 ng/mL
Geometric Coefficient of Variation 61.9
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 1, Day 15: 2 hours postdose
213 ng/mL
Geometric Coefficient of Variation 174.3
140 ng/mL
Geometric Coefficient of Variation 103.7
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 1, Day 15: 4 hours postdose
272 ng/mL
Geometric Coefficient of Variation 137.9
139 ng/mL
Geometric Coefficient of Variation 69.3
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 2, Day 1: predose
46.7 ng/mL
Geometric Coefficient of Variation 138.6
25.3 ng/mL
Geometric Coefficient of Variation 49.8
Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
Cycle 2, Day 1: 1-4 hours postdose
243 ng/mL
Geometric Coefficient of Variation 94.4
145 ng/mL
Geometric Coefficient of Variation 80.9

SECONDARY outcome

Timeframe: Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)

Population: The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data. Data were only analyzed in ipatasertib treatment arms. Total number analyzed represents all participants with evaluations at one or more time points.

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Outcome measures

Outcome measures
Measure
Phase Ib: Ipatasertib 400 mg
n=82 Participants
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=86 Participants
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
Cycle 1, Day 1: 1 hour postdose
34.7 ng/mL
Geometric Coefficient of Variation 223.1
13.9 ng/mL
Geometric Coefficient of Variation 268.9
Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
Cycle 1, Day 1: 4 hours postdose
101 ng/mL
Geometric Coefficient of Variation 61.8
42.9 ng/mL
Geometric Coefficient of Variation 96.6
Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
Cycle 1, Day 15: predose
44.1 ng/mL
Geometric Coefficient of Variation 92.4
20.4 ng/mL
Geometric Coefficient of Variation 59.2
Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
Cycle 1, Day 15: 2 hours postdose
121 ng/mL
Geometric Coefficient of Variation 159.4
78.0 ng/mL
Geometric Coefficient of Variation 93.0
Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
Cycle 1, Day 15: 4 hours postdose
178 ng/mL
Geometric Coefficient of Variation 134.0
101 ng/mL
Geometric Coefficient of Variation 61.0

Adverse Events

Phase Ib: Ipatasertib 400 mg

Serious events: 9 serious events
Other events: 14 other events
Deaths: 1 deaths

Phase Ib: Apitolisib 30 mg

Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths

Phase II: Ipatasertib 400 mg + Abiraterone

Serious events: 43 serious events
Other events: 82 other events
Deaths: 67 deaths

Phase II: Ipatasertib 200 mg + Abiraterone

Serious events: 42 serious events
Other events: 79 other events
Deaths: 71 deaths

Phase II: Placebo + Abiraterone

Serious events: 18 serious events
Other events: 76 other events
Deaths: 68 deaths

Safety Cohort: Ipatasertib 400 mg + Abiraterone

Serious events: 6 serious events
Other events: 25 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Phase Ib: Ipatasertib 400 mg
n=14 participants at risk
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 participants at risk
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 400 mg + Abiraterone
n=84 participants at risk
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 200 mg + Abiraterone
n=88 participants at risk
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=81 participants at risk
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Safety Cohort: Ipatasertib 400 mg + Abiraterone
n=25 participants at risk
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
Gastrointestinal disorders
COLITIS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
CONSTIPATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
DIARRHOEA
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
DYSPEPSIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Blood and lymphatic system disorders
ANAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Blood and lymphatic system disorders
COAGULOPATHY
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Blood and lymphatic system disorders
HAEMOLYTIC URAEMIC SYNDROME
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
ATRIAL FIBRILLATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
ATRIOVENTRICULAR BLOCK
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
BRADYCARDIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
CARDIAC FAILURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
CARDIAC FAILURE ACUTE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
LEFT VENTRICULAR FAILURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Eye disorders
CHORIORETINOPATHY
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ABDOMINAL PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ASCITES
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ENTEROCOLITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
FAECALOMA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
HAEMATOCHEZIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
NAUSEA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
PHARYNGO-OESOPHAGEAL DIVERTICULUM
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
VOMITING
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
ASTHENIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
DEATH
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
DISEASE PROGRESSION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
FATIGUE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
MALAISE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
PAIN
7.1%
1/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
PYREXIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
CELLULITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
GASTROENTERITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
OSTEOMYELITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
PNEUMONIA
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
PYELONEPHRITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
PYELONEPHRITIS ACUTE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
RESPIRATORY TRACT INFECTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
SEPSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.4%
3/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
SEPTIC SHOCK
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
SPINAL CORD INFECTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
TUBERCULOSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
URINARY TRACT INFECTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.0%
5/84 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
UROSEPSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
VASCULAR DEVICE INFECTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
FALL
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
RADIUS FRACTURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
RIB FRACTURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
SKULL FRACTURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
ULNA FRACTURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
HAEMATOCRIT DECREASED
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
HAEMOGLOBIN DECREASED
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
DEHYDRATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
DIABETIC METABOLIC DECOMPENSATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
FAILURE TO THRIVE
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPERGLYCAEMIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOGLYCAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
KETOACIDOSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
BACK PAIN
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
BONE PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
HAEMATOMA MUSCLE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
SPINAL PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATIC ADENOMA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL CARCINOMA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
DYSPHAGIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ENTERITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
CEREBRAL HAEMATOMA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
CEREBRAL HAEMORRHAGE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
DIZZINESS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
ISCHAEMIC STROKE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
NERVOUS SYSTEM DISORDER
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
SPINAL CORD COMPRESSION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
SYNCOPE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
VASCULAR ENCEPHALOPATHY
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Psychiatric disorders
CONFUSIONAL STATE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
ACUTE KIDNEY INJURY
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
BLADDER PERFORATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
CALCULUS URINARY
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
HAEMATURIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
NEPHROLITHIASIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
NEPHROPATHY TOXIC
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
RENAL COLIC
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
RENAL FAILURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
URETERIC OBSTRUCTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
URETERIC STENOSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
URETEROLITHIASIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
URINARY RETENTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Reproductive system and breast disorders
PELVIC PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Reproductive system and breast disorders
PROSTATITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
RASH
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
AORTIC ANEURYSM RUPTURE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
DEEP VEIN THROMBOSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
HYPOTENSION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
PELVIC VENOUS THROMBOSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
THROMBOSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
MALNUTRITION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

Other adverse events

Other adverse events
Measure
Phase Ib: Ipatasertib 400 mg
n=14 participants at risk
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase Ib: Apitolisib 30 mg
n=6 participants at risk
Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 400 mg + Abiraterone
n=84 participants at risk
Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Ipatasertib 200 mg + Abiraterone
n=88 participants at risk
Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Phase II: Placebo + Abiraterone
n=81 participants at risk
Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Safety Cohort: Ipatasertib 400 mg + Abiraterone
n=25 participants at risk
Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
Blood and lymphatic system disorders
ANAEMIA
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
22.6%
19/84 • Number of events 25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
20.5%
18/88 • Number of events 37 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
9.9%
8/81 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Blood and lymphatic system disorders
PANCYTOPENIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Eye disorders
VISION BLURRED
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ABDOMINAL PAIN
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.7%
9/84 • Number of events 12 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.4%
10/88 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
9.5%
8/84 • Number of events 10 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.2%
5/81 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
CHEILOSIS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
CONSTIPATION
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
9.5%
8/84 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
20.5%
18/88 • Number of events 26 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
19.8%
16/81 • Number of events 22 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
DIARRHOEA
64.3%
9/14 • Number of events 14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
66.7%
4/6 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
77.4%
65/84 • Number of events 198 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
47.7%
42/88 • Number of events 72 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
24.7%
20/81 • Number of events 36 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
68.0%
17/25 • Number of events 63 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
DRY MOUTH
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.9%
4/81 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
DYSPEPSIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.7%
9/84 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
7/88 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ERUCTATION
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
FLATULENCE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
NAUSEA
42.9%
6/14 • Number of events 11 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
66.7%
4/6 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
53.6%
45/84 • Number of events 74 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
35.2%
31/88 • Number of events 44 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
25.9%
21/81 • Number of events 30 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
48.0%
12/25 • Number of events 24 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
ORAL DISORDER
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
RECTAL HAEMORRHAGE
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
RETCHING
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
TONGUE DISCOLOURATION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Gastrointestinal disorders
VOMITING
64.3%
9/14 • Number of events 14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
50.0%
3/6 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
32.1%
27/84 • Number of events 42 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
27.3%
24/88 • Number of events 69 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
14.8%
12/81 • Number of events 24 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
20.0%
5/25 • Number of events 12 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
ASTHENIA
28.6%
4/14 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
27.4%
23/84 • Number of events 36 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
22.7%
20/88 • Number of events 24 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.0%
13/81 • Number of events 15 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
FATIGUE
64.3%
9/14 • Number of events 11 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
26.2%
22/84 • Number of events 36 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
28.4%
25/88 • Number of events 37 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
29.6%
24/81 • Number of events 32 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
20.0%
5/25 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
GAIT DISTURBANCE
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
MUCOSAL INFLAMMATION
21.4%
3/14 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
OEDEMA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
OEDEMA PERIPHERAL
7.1%
1/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.9%
10/84 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.2%
9/88 • Number of events 11 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.6%
7/81 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.3%
7/84 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.2%
9/88 • Number of events 14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.5%
2/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
PYREXIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
50.0%
3/6 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
14.3%
12/84 • Number of events 28 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
13.6%
12/88 • Number of events 16 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.1%
9/81 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.0%
4/25 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
General disorders
THIRST
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
INFLUENZA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.0%
5/84 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
NASOPHARYNGITIS
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.0%
5/84 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
7/88 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
URINARY TRACT INFECTION
14.3%
2/14 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
14/84 • Number of events 16 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
7/88 • Number of events 12 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.4%
6/81 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Infections and infestations
FUNGAL URETHRITIS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
MENISCUS INJURY
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.0%
5/84 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 10 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
BLOOD CREATININE INCREASED
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.3%
7/84 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
BLOOD URINE PRESENT
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
DECREASED APPETITE
35.7%
5/14 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
25.0%
21/84 • Number of events 31 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
23.9%
21/88 • Number of events 28 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
14.8%
12/81 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
DEHYDRATION
21.4%
3/14 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.5%
2/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
FAILURE TO THRIVE
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPERGLYCAEMIA
42.9%
6/14 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
22.6%
19/84 • Number of events 26 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
7/88 • Number of events 12 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.2%
5/81 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
32.0%
8/25 • Number of events 18 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPERKALAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.4%
3/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOCALCAEMIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.1%
6/84 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.9%
4/81 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOKALAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
9.5%
8/84 • Number of events 20 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.8%
6/88 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.6%
7/81 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.0%
4/25 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.1%
6/84 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.5%
2/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOVOLAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
INCREASED APPETITE
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
14.3%
2/14 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
20.2%
17/84 • Number of events 33 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
19.3%
17/88 • Number of events 30 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
25.9%
21/81 • Number of events 27 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
BACK PAIN
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
21.4%
18/84 • Number of events 25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
22.7%
20/88 • Number of events 41 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
24.7%
20/81 • Number of events 28 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
BONE PAIN
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
14.3%
12/84 • Number of events 20 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
13.6%
12/88 • Number of events 15 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
22.2%
18/81 • Number of events 20 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
FLANK PAIN
7.1%
1/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.4%
3/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.8%
6/88 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.5%
2/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
7/88 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.3%
7/84 • Number of events 19 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.6%
7/81 • Number of events 10 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
MYALGIA
28.6%
4/14 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.1%
6/84 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.4%
3/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.2%
5/81 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
NECK PAIN
7.1%
1/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
14.3%
2/14 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
15.5%
13/84 • Number of events 15 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
14.8%
13/88 • Number of events 24 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
9.9%
8/81 • Number of events 14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.0%
4/25 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Musculoskeletal and connective tissue disorders
PAIN IN JAW
7.1%
1/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
DIZZINESS
21.4%
3/14 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
13.1%
11/84 • Number of events 16 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.8%
6/88 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.2%
5/81 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
DYSGEUSIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.1%
6/84 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
HEADACHE
14.3%
2/14 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.7%
9/84 • Number of events 14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.4%
6/81 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
HYPOAESTHESIA
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
LETHARGY
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
PARAESTHESIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
SOMNOLENCE
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Psychiatric disorders
AGITATION
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Psychiatric disorders
ANXIETY
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Psychiatric disorders
DEPRESSION
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.4%
3/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Psychiatric disorders
INSOMNIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.7%
9/84 • Number of events 11 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.4%
10/88 • Number of events 10 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.2%
5/81 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Psychiatric disorders
RESTLESSNESS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
ACUTE KIDNEY INJURY
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
DYSURIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
9.5%
8/84 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.5%
2/81 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
HAEMATURIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.9%
10/84 • Number of events 16 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.8%
6/88 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.2%
5/81 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
HYPERTONIC BLADDER
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
URINARY INCONTINENCE
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
POLLAKIURIA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.2%
9/88 • Number of events 11 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Renal and urinary disorders
RENAL PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
14.3%
2/14 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
33.3%
2/6 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.8%
4/84 • Number of events 9 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
28.0%
7/25 • Number of events 14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Reproductive system and breast disorders
PELVIC PAIN
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.3%
7/84 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Reproductive system and breast disorders
PENILE PAIN
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
COUGH
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.3%
7/84 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
6.8%
6/88 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.6%
7/81 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
DRY THROAT
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
HOT FLUSH
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.9%
10/84 • Number of events 10 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.6%
7/81 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
13.1%
11/84 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
10.2%
9/88 • Number of events 10 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
7.4%
6/81 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
14.3%
2/14 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.4%
2/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.5%
4/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.5%
2/81 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Respiratory, thoracic and mediastinal disorders
WHEEZING
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
HYPERTENSION
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
13.1%
11/84 • Number of events 15 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
13.6%
12/88 • Number of events 13 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.1%
9/81 • Number of events 12 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
ECCHYMOSIS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
HAEMORRHAGE SUBCUTANEOUS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
NIGHT SWEATS
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.0%
1/25 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Skin and subcutaneous tissue disorders
RASH
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
50.0%
3/6 • Number of events 5 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
11.9%
10/84 • Number of events 16 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
5.7%
5/88 • Number of events 7 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Vascular disorders
HYPOTENSION
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
16.7%
1/6 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Injury, poisoning and procedural complications
FALL
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.7%
3/81 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
4.8%
4/84 • Number of events 8 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
2.3%
2/88 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 12 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
WEIGHT DECREASED
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.6%
3/84 • Number of events 6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
3.4%
3/88 • Number of events 4 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
12.0%
3/25 • Number of events 3 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Metabolism and nutrition disorders
HYPOGLYCAEMIA
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/81 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
TASTE DISORDER
7.1%
1/14 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/25 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Nervous system disorders
TREMOR
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/84 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.1%
1/88 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
Investigations
BLOOD TRIGLYCERIDES INCREASED
0.00%
0/14 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/6 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
1.2%
1/84 • Number of events 1 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/88 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
0.00%
0/81 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.
8.0%
2/25 • Number of events 2 • Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)
The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER