Trial Outcomes & Findings for Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer (NCT NCT03072238)

NCT ID: NCT03072238

Last Updated: 2025-06-06

Results Overview

rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The Kaplan-Meier (KM) estimate was used to determine the median rPFS.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1101 participants
• Primary outcome timeframe: Up to approximately 32 months
• Results posted on: 2025-06-06

Participant Flow

A total of 1101 male participants with metastatic castrate-resistant prostate cancer (mCRPC) took part in the study at 181 investigative sites across 26 countries from June 30, 2017 to April 24, 2024.

Participants were randomized in a 1:1 ratio to one of the two following treatment arms: abiraterone plus prednisone/prednisolone plus ipatasertib (Ipat + Abi) and abiraterone plus prednisone/prednisolone plus placebo (Pbo + Abi). 3 participants in the Pbo+Abi arm and 1 participant in the Ipat +Abi arm did not receive any treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.

Participant milestones

Measure	Pbo + Abi Participants received matching placebo along with abiraterone 1000 milligrams (mg), once a day (QD) and prednisone/prednisolone, 5 mg, twice a day (BID) administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Overall Study STARTED	554	547
Overall Study Safety Evaluable (SE) Population	546	551
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	554	547

Reasons for withdrawal

Measure	Pbo + Abi Participants received matching placebo along with abiraterone 1000 milligrams (mg), once a day (QD) and prednisone/prednisolone, 5 mg, twice a day (BID) administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Overall Study Withdrawal by Subject	44	64
Overall Study Lost to Follow-up	14	5
Overall Study Physician Decision	4	6
Overall Study Death	351	318
Overall Study Progressive Disease	3	4
Overall Study Reason Not Specified	138	150

Baseline Characteristics

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Total n=1101 Participants Total of all reporting groups
Age, Continuous	69.7 years STANDARD_DEVIATION 8.2 • n=5 Participants	69.4 years STANDARD_DEVIATION 8.0 • n=7 Participants	69.5 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	554 Participants n=5 Participants	547 Participants n=7 Participants	1101 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	65 Participants n=5 Participants	66 Participants n=7 Participants	131 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	469 Participants n=5 Participants	452 Participants n=7 Participants	921 Participants n=5 Participants
Race/Ethnicity, Customized Not Stated	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Asian	109 Participants n=5 Participants	110 Participants n=7 Participants	219 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	386 Participants n=5 Participants	376 Participants n=7 Participants	762 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: PTEN loss population included all randomized participants with PTEN loss tumors by immunohistochemistry (IHC), regardless of whether or not the participant received the assigned treatment.

rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The Kaplan-Meier (KM) estimate was used to determine the median rPFS.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population	16.5 months Interval 13.9 to 17.0	18.5 months Interval 16.3 to 22.1

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to RECIST v1.1 criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The KM estimate was used to determine the median rPFS.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population	16.6 months Interval 15.6 to 19.1	19.2 months Interval 16.5 to 22.3

SECONDARY outcome

Timeframe: Up to approximately 6.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Overall Survival (OS) in PTEN-loss Population	35.8 months Interval 30.8 to 39.6	36.8 months Interval 31.4 to 42.1

SECONDARY outcome

Timeframe: Up to approximately 6.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
OS in ITT Population	36.5 months Interval 33.9 to 39.4	39.4 months Interval 36.5 to 42.9

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point numeric rating scale [NRS], with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Pain Progression in PTEN-loss Population	17.6 months Interval 14.6 to 27.7	25.8 months Interval 17.5 to 43.3

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point NRS, with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Pain Progression in ITT Population	21.9 months Interval 17.5 to 27.7	25.9 months Interval 20.2 to 40.7

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Initiation of Cytotoxic Chemotherapy for Prostate Cancer (PC) in PTEN-loss Population	33.6 months Interval 26.3 to 38.8	36.3 months Interval 30.5 to 58.6

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Initiation of Cytotoxic Chemotherapy for PC in ITT Population	35.5 months Interval 30.9 to 40.3	40.4 months Interval 34.7 to The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive&social), 3 symptom scales (fatigue,nausea&vomiting,pain), global health/quality of life (GHS/QoL)&6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea&financial difficulties). PF scale has 5 questions about participants physical functioning&daily activities. RF scale has 2 questions about work/daily activities&hobbies/leisurely activities. PF&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF)&better functioning/support.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Function Deterioration Per European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function (PF) Scale and Role Function (RF) Scale in PTEN-loss Population	15.7 months Interval 12.1 to 21.2	12.5 months Interval 9.3 to 16.3

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive & social), 3 symptom scales (fatigue,nausea&vomiting,pain), GHS/QoL & 6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea & financial difficulties). PF scale has 5 questions about participants physical functioning & daily activities. RF scale has 2 questions about work/daily activities & hobbies/leisurely activities. PF&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF) & better functioning/support.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Function Deterioration Per EORTC QLQ-C30 PF Scale and RF Scale in ITT Population	14.8 months Interval 12.0 to 18.2	9.2 months Interval 7.4 to 11.1

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

Time to PSA progression was defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression was defined as a PSA increase that was ≥ 25% and ≥ 2 nanograms per milliliters (ng/mL) above the baseline or the nadir, which was confirmed by a second value ≥ 3 weeks later. KM estimate was used to determine the median time to PSA.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Prostate-specific Antigen (PSA) Progression, Per the PCWG3 Criteria in PTEN-loss Population	7.6 months Interval 6.5 to 9.3	12.6 months Interval 10.2 to 15.3

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

Time to PSA progression was defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression was defined as a PSA increase that was ≥ 25% and ≥ 2 ng/mL above the baseline or the nadir, which was confirmed by a second value ≥ 3 weeks later. KM estimate was used to determine the median time to PSA.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to PSA Progression, Per the PCWG3 Criteria in ITT Population	8.3 months Interval 7.4 to 9.3	12.6 months Interval 10.3 to 14.8

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

Time to first opioid use was defined as the time interval from the date of randomization to the date of an initiation of opioid analgesic use for cancer-related pain, and consumption reported on at least 7 consecutive days. KM estimate was used to determine the median time to first opioid use.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to First Opioid Use in PTEN-loss Population	NA months Interval 14.1 to The median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.	NA months Interval 21.5 to The median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

Time to first opioid use was defined as the time interval from the date of randomization to the date of an initiation of opioid analgesic use for cancer-related pain, and consumption reported on at least 7 consecutive days. KM estimate was used to determine the median time to first opioid use.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to First Opioid Use in ITT Population	NA months The median and 95% CI were not estimable due to insufficient number of participants with events.	NA months The median and 95% CI were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

Time to SSE was defined as the time from randomization to the first occurrence of an SSE. A SSE was defined using one of the following: use of external-beam radiotherapy to relieve skeletal symptoms (including initiation of radium-223 to treat symptoms of bone metastases); occurrence of a new symptomatic pathological bone fracture (vertebral or non-vertebral); clinically apparent occurrence of spinal cord compression, or a tumor-related orthopedic surgical intervention. KM estimates were used to determine the median time to SSE.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to Symptomatic Skeletal Event (SSE) in PTEN-loss Population	NA months The median and 95% CI were not estimable due to insufficient number of participants with events.	NA months The median and 95% CI were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment.

Time to SSE was defined as the time from randomization to the first occurrence of an SSE. A SSE was defined using one of the following: use of external-beam radiotherapy to relieve skeletal symptoms (including initiation of radium-223 to treat symptoms of bone metastases); occurrence of a new symptomatic pathological bone fracture (vertebral or non-vertebral); clinically apparent occurrence of spinal cord compression, or a tumor-related orthopedic surgical intervention. KM estimates were used to determine the median time to SSE.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=547 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Time to SSE in ITT Population	NA months The median and 95% CI were not estimable due to insufficient number of participants with events.	NA months The median and 95% CI were not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with measurable disease at baseline.

ORR was defined as the percentage of participants who had an objective response (OR) with measurable disease at baseline. An OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria in participants with measurable disease at baseline. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.

Outcome measures

Measure	Pbo + Abi n=96 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=99 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Objective Response Rate (ORR) Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in PTEN-loss Population	42.7 percentage of participants Interval 32.66 to 53.22	63.6 percentage of participants Interval 53.36 to 73.07

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment. Overall number analyzed is the number of participants with measurable disease at baseline.

ORR was defined as the percentage of participants who had an OR with measurable disease at baseline. An OR was defined as a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria in participants with measurable disease at baseline. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method. Percentage have been rounded off.

Outcome measures

Measure	Pbo + Abi n=225 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=201 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
ORR Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in ITT Population	46.2 percentage of participants Interval 39.57 to 52.97	62.7 percentage of participants Interval 55.6 to 69.39

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with objective response i.e. responders.

DOCR was defined as the time from the first documented OR (CR or PR) to documented PD as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. DOR was estimated using the KM methodology.

Outcome measures

Measure	Pbo + Abi n=41 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=63 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Duration of Confirmed Response (DOCR) in PTEN-loss Population	14.4 months Interval 12.1 to 18.5	19.6 months Interval 15.3 to 24.4

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment. Overall number analyzed is the number of participants with objective response i.e. responders.

DOCR was defined as the time from the first documented OR (CR or PR) to documented PD as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occured first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. DOR was estimated using the KM methodology.

Outcome measures

Measure	Pbo + Abi n=104 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=126 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
DOCR in ITT Population	16.3 months Interval 13.4 to 20.2	18.2 months Interval 14.4 to 22.1

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.

PSA response rate was defined as the percentage of participants achieving a PSA decline ≥ 50% from baseline. Participants without a post-baseline PSA assessment were considered to be non-responders. Percentages have been rounded off.

Outcome measures

Measure	Pbo + Abi n=261 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=260 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
PSA Response Rate in PTEN-loss Population	71.6 percentage of participants Interval 65.76 to 77.03	83.5 percentage of participants Interval 78.38 to 87.77

SECONDARY outcome

Timeframe: Up to approximately 5.5 years

Population: ITT population included all randomized participants, whether or not the participants received the assigned treatment. Overall number analyzed included participants with data available for analysis.

PSA response rate was defined as the percentage of participants achieving a PSA decline ≥ 50% from baseline. Participants without a post-baseline PSA assessment were considered to be non-responders. Percentages have been rounded off.

Outcome measures

Measure	Pbo + Abi n=554 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=546 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
PSA Response Rate in ITT Population	75.5 percentage of participants Interval 71.65 to 78.98	81.3 percentage of participants Interval 77.79 to 84.5

SECONDARY outcome

Timeframe: Up to approximately 32 months

Population: PTEN loss population included all randomized participants with PTEN loss tumors by NGS, regardless of whether or not the participant received the assigned treatment. Number analyzed is the number of participants with data available for analyses.

rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator using the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later.

Outcome measures

Measure	Pbo + Abi n=103 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=105 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Investigator-assessed rPFS Per PCWG3 Criteria in PTEN-loss Population by Next-generation Sequencing (NGS)	14.2 months Interval 10.9 to 18.7	19.1 months Interval 13.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 28 days after last study drug administration (approximately 6.5 years)

Population: SE population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study were also considered as AEs. Percentages have been rounded off.

Outcome measures

Measure	Pbo + Abi n=546 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=551 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Percentage of Participants With Adverse Events (AEs)	96.2 percentage of participants	99.6 percentage of participants

SECONDARY outcome

Timeframe: 1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days)

Population: Pharmacokinetic (PK)-evaluable population included all participants who received ipatasertib treatment with evaluable PK samples. Number analyzed per timepoint are unique number of participants out all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.

Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.

Outcome measures

Measure	Pbo + Abi n=544 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Plasma Concentrations of Ipatasertib at Specified Timepoints Cycle 1 Day 1 Post-dose	212 ng/mL Geometric Coefficient of Variation 158	—
Plasma Concentrations of Ipatasertib at Specified Timepoints Cycle 1 Day 15 Pre-dose	46.8 ng/mL Geometric Coefficient of Variation 160	—
Plasma Concentrations of Ipatasertib at Specified Timepoints Cycle 1 Day 15 Post-dose	247 ng/mL Geometric Coefficient of Variation 138	—
Plasma Concentrations of Ipatasertib at Specified Timepoints Cycle 3 Day 1 Pre-dose	35.4 ng/mL Geometric Coefficient of Variation 256	—
Plasma Concentrations of Ipatasertib at Specified Timepoints Cycle 3 Day 1 Post-dose	207 ng/mL Geometric Coefficient of Variation 156	—
Plasma Concentrations of Ipatasertib at Specified Timepoints Cycle 6 Day 1 Pre-dose	46.1 ng/mL Geometric Coefficient of Variation 134	—

SECONDARY outcome

Timeframe: Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days)

Population: PK-evaluable population included all participants who received abiraterone treatment with evaluable PK samples. Overall number analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint. Different participants may have contributed data for each timepoint.

Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.

Outcome measures

Measure	Pbo + Abi n=537 Participants Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=520 Participants Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Plasma Concentrations of Abiraterone at Specified Timepoints Cycle 3 Day 1	10.4 ng/mL Geometric Coefficient of Variation 120	9.55 ng/mL Geometric Coefficient of Variation 159
Plasma Concentrations of Abiraterone at Specified Timepoints Cycle 1 Day 15	11.2 ng/mL Geometric Coefficient of Variation 124	9.40 ng/mL Geometric Coefficient of Variation 159

Adverse Events

Pbo + Abi

Serious events: 158 serious events

Other events: 496 other events

Deaths: 358 deaths

Ipat + Abi

Serious events: 252 serious events

Other events: 541 other events

Deaths: 331 deaths

Serious adverse events

Measure	Pbo + Abi n=546 participants at risk Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=551 participants at risk Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Blood and lymphatic system disorders Anaemia	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	1.3% 7/551 • Number of events 7 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Blood and lymphatic system disorders Bicytopenia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Blood and lymphatic system disorders Haemolysis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Blood and lymphatic system disorders Thrombocytopenia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Acute coronary syndrome	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Acute left ventricular failure	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Acute myocardial infarction	1.3% 7/546 • Number of events 7 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Angina pectoris	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Angina unstable	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Atrial fibrillation	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Atrial flutter	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Bradycardia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Cardiac arrest	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.73% 4/551 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Cardiac failure	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Cardiac failure congestive	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Cardiomyopathy	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Cor pulmonale	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Coronary artery stenosis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Myocardial infarction	0.55% 3/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	1.3% 7/551 • Number of events 7 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Myocardial ischaemia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Sinus tachycardia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Eye disorders Cataract	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Eye disorders Retinal detachment	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Abdominal distension	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Abdominal pain	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Chronic gastritis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Colonic fistula	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	2.5% 14/551 • Number of events 14 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Dysphagia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Enterocolitis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Gastritis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Gastritis haemorrhagic	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Haematemesis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Ileus	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Ileus paralytic	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Intestinal obstruction	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Ischaemic enteritis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Large intestine polyp	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Nausea	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Oesophagitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Pancreatitis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Rectal haemorrhage	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Small intestinal perforation	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Volvulus	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Vomiting	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.73% 4/551 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Adverse drug reaction	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Asthenia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Chest pain	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Death	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.73% 4/551 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Fatigue	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders General physical health deterioration	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Hernia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Impaired healing	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Non-cardiac chest pain	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Oedema peripheral	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Pain	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Pyrexia	0.55% 3/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.73% 4/551 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Sudden cardiac death	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Cholangitis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Cholecystitis	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Haemobilia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Hepatitis acute	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Hypertransaminasaemia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Immune system disorders Anaphylactic reaction	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Acute sinusitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Anal abscess	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Bronchiolitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Bronchitis	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Bullous erysipelas	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations COVID-19	0.73% 4/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.91% 5/551 • Number of events 5 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Cellulitis	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Cystitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Diverticulitis	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Enterocolitis infectious	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Febrile infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Gastroenteritis	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Gastroenteritis bacterial	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Gastroenteritis salmonella	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Gingivitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Infection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Infectious pleural effusion	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Influenza	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Localised infection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Lower respiratory tract infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Opportunistic infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Osteomyelitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia	1.8% 10/546 • Number of events 10 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	2.9% 16/551 • Number of events 17 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia bacterial	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia influenzal	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia legionella	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia pneumococcal	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pulpitis dental	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pyelonephritis	0.37% 2/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pyelonephritis acute	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Rash pustular	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Renal abscess	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Respiratory tract infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Sepsis	1.1% 6/546 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	1.1% 6/551 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Septic shock	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.91% 5/551 • Number of events 5 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Skin infection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Tooth infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Tracheobronchitis	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Upper respiratory tract infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Urinary tract infection	1.1% 6/546 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	2.2% 12/551 • Number of events 15 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Fall	0.73% 4/546 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Forearm fracture	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Fracture displacement	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Head injury	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Hip fracture	0.73% 4/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.73% 4/551 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Humerus fracture	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Hypobarism	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Pneumonitis chemical	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Radiation proctitis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Skull fracture	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Spinal compression fracture	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Subdural haemorrhage	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Tendon rupture	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Alanine aminotransferase increased	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	1.3% 7/551 • Number of events 7 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Aspartate aminotransferase increased	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.91% 5/551 • Number of events 5 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Blood bilirubin increased	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Glycosylated haemoglobin increased	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Transaminases increased	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	2.2% 12/551 • Number of events 13 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Electrolyte imbalance	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	4.5% 25/551 • Number of events 26 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypokalaemia	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypophosphataemia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Back pain	1.1% 6/546 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	1.1% 6/551 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Muscular weakness	0.73% 4/546 • Number of events 5 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Cerebral haemorrhage	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Cerebral ischaemia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Cerebrospinal fluid leakage	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Cerebrovascular accident	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Dysarthria	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Headache	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Paraplegia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Sciatica	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Seizure	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Spinal cord compression	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Syncope	0.37% 2/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Product Issues Device dislocation	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Psychiatric disorders Confusional state	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Psychiatric disorders Disorientation	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Psychiatric disorders Psychotic disorder	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Acute kidney injury	0.73% 4/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.91% 5/551 • Number of events 5 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Dysuria	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Haematuria	1.1% 6/546 • Number of events 7 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	2.0% 11/551 • Number of events 13 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Hydronephrosis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Nephrolithiasis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Renal failure	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Renal tubular necrosis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Ureterolithiasis	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Urethral stenosis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Urinary retention	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Urinary tract obstruction	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Reproductive system and breast disorders Prostatitis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.55% 3/546 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.73% 4/551 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	2.7% 15/551 • Number of events 17 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.91% 5/551 • Number of events 5 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Artery dissection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Deep vein thrombosis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.54% 3/551 • Number of events 3 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Hypertension	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Hypotension	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Venous thrombosis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Cardiac failure acute	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Cardiac disorders Myocarditis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Ear and labyrinth disorders Vertigo	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Endocrine disorders Adrenal insufficiency	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Gastric ulcer	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Inguinal hernia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Superior mesenteric artery dissection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Biliary obstruction	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Hepatobiliary disorders Cholecystitis acute	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Abdominal infection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Appendicitis perforated	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Bacterial abdominal infection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations COVID-19 pneumonia	0.73% 4/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	1.1% 6/551 • Number of events 6 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Device related infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Endocarditis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Enteritis infectious	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Gastroenteritis viral	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Herpes zoster	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Klebsiella bacteraemia	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia aspiration	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pneumonia viral	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Prostate infection	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pseudomonas infection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Pulmonary sepsis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Sinusitis	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Urosepsis	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Fracture	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Sacral pain	0.55% 3/546 • Number of events 4 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of ampulla of Vater	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.37% 2/546 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer stage 0	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Cerebral infarction	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.00% 0/551 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Dizziness	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Monoparesis	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Polyneuropathy	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Chronic kidney disease	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Urinary fistula	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Urinary incontinence	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.18% 1/546 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Aortic dissection	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Peripheral ischaemia	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.36% 2/551 • Number of events 2 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Peripheral vascular disorder	0.00% 0/546 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	0.18% 1/551 • Number of events 1 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.

Other adverse events

Measure	Pbo + Abi n=546 participants at risk Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.	Ipat + Abi n=551 participants at risk Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Blood and lymphatic system disorders Anaemia	13.7% 75/546 • Number of events 107 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	23.0% 127/551 • Number of events 192 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Abdominal pain	4.0% 22/546 • Number of events 24 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.8% 32/551 • Number of events 38 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Constipation	17.4% 95/546 • Number of events 111 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	10.0% 55/551 • Number of events 60 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Diarrhoea	25.1% 137/546 • Number of events 193 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	80.0% 441/551 • Number of events 969 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Dyspepsia	4.9% 27/546 • Number of events 33 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	6.7% 37/551 • Number of events 40 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Nausea	11.9% 65/546 • Number of events 76 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	28.9% 159/551 • Number of events 214 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Gastrointestinal disorders Vomiting	10.4% 57/546 • Number of events 75 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	17.8% 98/551 • Number of events 152 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Asthenia	14.3% 78/546 • Number of events 99 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	18.7% 103/551 • Number of events 148 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Fatigue	20.3% 111/546 • Number of events 141 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	23.4% 129/551 • Number of events 148 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Oedema peripheral	10.3% 56/546 • Number of events 73 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	16.2% 89/551 • Number of events 105 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
General disorders Pyrexia	4.2% 23/546 • Number of events 26 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	6.9% 38/551 • Number of events 45 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Nasopharyngitis	9.5% 52/546 • Number of events 72 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.7% 48/551 • Number of events 68 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Upper respiratory tract infection	9.2% 50/546 • Number of events 60 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	7.1% 39/551 • Number of events 52 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Infections and infestations Urinary tract infection	8.4% 46/546 • Number of events 61 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	9.8% 54/551 • Number of events 87 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Injury, poisoning and procedural complications Fall	9.7% 53/546 • Number of events 72 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	7.6% 42/551 • Number of events 58 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Alanine aminotransferase increased	10.3% 56/546 • Number of events 67 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	20.0% 110/551 • Number of events 129 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Aspartate aminotransferase increased	10.6% 58/546 • Number of events 71 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	17.1% 94/551 • Number of events 101 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Blood creatinine increased	4.9% 27/546 • Number of events 35 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	7.4% 41/551 • Number of events 56 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Weight decreased	4.2% 23/546 • Number of events 27 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	14.2% 78/551 • Number of events 94 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Decreased appetite	11.4% 62/546 • Number of events 78 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	19.4% 107/551 • Number of events 128 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hyperglycaemia	17.4% 95/546 • Number of events 155 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	39.9% 220/551 • Number of events 366 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.1% 28/546 • Number of events 36 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	6.5% 36/551 • Number of events 43 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypokalaemia	8.1% 44/546 • Number of events 69 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.7% 48/551 • Number of events 70 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	21.8% 119/546 • Number of events 155 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	18.5% 102/551 • Number of events 139 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Back pain	23.3% 127/546 • Number of events 164 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	19.1% 105/551 • Number of events 135 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Bone pain	6.8% 37/546 • Number of events 52 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.5% 47/551 • Number of events 52 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	10.3% 56/546 • Number of events 68 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.2% 45/551 • Number of events 54 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Dizziness	6.4% 35/546 • Number of events 46 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	7.4% 41/551 • Number of events 47 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Nervous system disorders Headache	8.8% 48/546 • Number of events 62 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	10.5% 58/551 • Number of events 68 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Psychiatric disorders Insomnia	8.1% 44/546 • Number of events 50 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.3% 29/551 • Number of events 31 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Haematuria	6.0% 33/546 • Number of events 41 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	6.4% 35/551 • Number of events 50 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	9.2% 50/546 • Number of events 55 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.5% 47/551 • Number of events 52 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 29/546 • Number of events 31 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	6.5% 36/551 • Number of events 37 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Pruritus	2.9% 16/546 • Number of events 18 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.7% 48/551 • Number of events 66 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Rash	8.8% 48/546 • Number of events 53 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	27.2% 150/551 • Number of events 193 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.5% 8/546 • Number of events 9 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	8.7% 48/551 • Number of events 67 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Hot flush	7.0% 38/546 • Number of events 42 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.1% 28/551 • Number of events 31 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Vascular disorders Hypertension	17.2% 94/546 • Number of events 125 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	15.6% 86/551 • Number of events 102 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Blood alkaline phosphatase increased	5.1% 28/546 • Number of events 32 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	4.9% 27/551 • Number of events 29 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Blood cholesterol increased	2.2% 12/546 • Number of events 12 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.1% 28/551 • Number of events 37 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Glycosylated haemoglobin increased	1.3% 7/546 • Number of events 7 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.4% 30/551 • Number of events 32 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Investigations Lipase increased	4.9% 27/546 • Number of events 44 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.4% 30/551 • Number of events 48 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Metabolism and nutrition disorders Hypercholesterolaemia	2.7% 15/546 • Number of events 20 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	6.0% 33/551 • Number of events 36 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 32/546 • Number of events 34 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	3.8% 21/551 • Number of events 28 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.
Renal and urinary disorders Dysuria	3.7% 20/546 • Number of events 23 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.	5.4% 30/551 • Number of events 33 • Up to approximately 6.5 years SE Population included all participants who received any amount of the study treatment. 5 participants randomized to the placebo arm took at least one dose of ipatasertib and hence were included in the Ipat + Abi arm for safety analysis.

Additional Information

Medical Communications

Hoffmann-La Roche

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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