Trial Outcomes & Findings for A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen (NCT NCT03016312)

NCT ID: NCT03016312

Last Updated: 2024-08-09

Results Overview

Overall Survival is defined as the time from randomization to death from any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 759 participants
• Primary outcome timeframe: Baseline until death from any cause (up to approximately 42 months)
• Results posted on: 2024-08-09

Participant Flow

Study was conducted at 155 centres in 21 countries.

Total 759 participants were randomized.

Participant milestones

Measure	Atezolizumab + Enzalutamide Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Overall Study STARTED	379	380
Overall Study Participants Received Treatment	375	375
Overall Study COMPLETED	17	10
Overall Study NOT COMPLETED	362	370

Reasons for withdrawal

Measure	Atezolizumab + Enzalutamide Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Overall Study discontinued before the treatment started	0	1
Overall Study Withdrawal by Subject	37	44
Overall Study Terminated by the Sponsor's decision	100	126
Overall Study Physician Decision	1	3
Overall Study Lost to Follow-up	12	12
Overall Study Death	210	184
Overall Study loss to contact	1	0
Overall Study started a new cancer therapy	1	0

Baseline Characteristics

A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen

Baseline characteristics by cohort

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Total n=759 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	90 Participants n=7 Participants	187 Participants n=5 Participants
Age, Categorical >=65 years	282 Participants n=5 Participants	290 Participants n=7 Participants	572 Participants n=5 Participants
Age, Continuous	70.5 Years STANDARD_DEVIATION 8.3 • n=5 Participants	70.6 Years STANDARD_DEVIATION 8.5 • n=7 Participants	70.5 Years STANDARD_DEVIATION 8.4 • 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	379 Participants n=5 Participants	380 Participants n=7 Participants	759 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	337 Participants n=5 Participants	345 Participants n=7 Participants	682 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	71 Participants n=5 Participants	65 Participants n=7 Participants	136 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	279 Participants n=5 Participants	287 Participants n=7 Participants	566 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until death from any cause (up to approximately 42 months)

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

Overall Survival is defined as the time from randomization to death from any cause.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Overall Survival (OS)	15.2 Months Interval 14.0 to 17.0	16.6 Months Interval 14.7 to 18.4

SECONDARY outcome

Timeframe: Months 6, 12

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Percentage of Participants Who Survived at Month 6 and 12 12 Months	60.61 Percentage of Participants Interval 55.52 to 65.71	64.65 Percentage of Participants Interval 59.6 to 69.7
Percentage of Participants Who Survived at Month 6 and 12 6 Months	85.12 Percentage of Participants Interval 81.45 to 88.78	85.32 Percentage of Participants Interval 81.67 to 88.97

SECONDARY outcome

Timeframe: Baseline up to end of study (up to approximately 42 months)

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Time to First Symptomatic Skeletal Event (SSE)	24.1 Months Interval 24.1 to Due to censoring, the upper limit was not estimable.	24.9 Months Interval 24.9 to Due to censoring, the upper limit was not estimable.

SECONDARY outcome

Timeframe: Baseline until disease progression or death from any cause (up to approximately 42 months)

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

rPFS is defined as the time from randomization to the earliest occurrence of one of the following:

• A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.
• Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1
• Death from any cause

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria	4.2 Months Interval 4.1 to 5.3	4.1 Months Interval 3.7 to 4.5

SECONDARY outcome

Timeframe: Months 6, 12

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

rPFS is defined as the time from randomization to the earliest occurrence of one of the following:

• A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.
• Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1
• Death from any cause

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria 6 months	41.84 Percentage of Participants Interval 36.09 to 47.6	39.64 Percentage of Participants Interval 33.86 to 45.42
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria 12 months	14.89 Percentage of Participants Interval 10.74 to 19.05	13.45 Percentage of Participants Interval 9.42 to 17.49

SECONDARY outcome

Timeframe: Baseline until disease progression (up to approximately 42 months)

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

PSA response rate, defined as a > 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline	25.9 Percentage of Participants Interval 21.5 to 30.5	24.2 Percentage of Participants Interval 20.0 to 28.7

SECONDARY outcome

Timeframe: Baseline until disease progression (up to approximately 42 months)

Population: The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants in the ITT population with measurable soft tissue lesions at baseline.

In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=379 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=380 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Time to PSA Progression, Assessed as Per PCWG3 Criteria	2.8 Months Interval 2.8 to 2.9	2.8 Months Interval 2.8 to 2.9

SECONDARY outcome

Timeframe: Baseline until disease progression or death from any cause (up to approximately 42 months)

Population: * Participants were classified as missing or unevaluable if no post-baseline response assessments were available or all post-baseline response baseline assessments were unevaluable. * Responders had to have a CR or PR on two consecutive occasions at least 6 weeks apart.

Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria

Outcome measures

Measure	Atezolizumab + Enzalutamide n=131 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=135 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria	13.7 Percentage of Participants Interval 8.4 to 20.7	7.4 Percentage of Participants Interval 3.7 to 13.0

SECONDARY outcome

Timeframe: Baseline up to end of study (up to approximately 42 month)

Population: The safety population is defined as participants who received any amount of any component of the study treatments (atezolizumab, or enzalutamide). Participants will be allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to enzalutamide alone who received at least one full or partial dose of atezolizumab will be included in the atezolizumab arm for safety)

Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=374 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=376 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Percentage of Participants With Adverse Events Total number of participants with at least one treatment related AE	78.1 Percentage of Participants	51.6 Percentage of Participants
Percentage of Participants With Adverse Events Total number of participants with at least one adverse event	96.8 Percentage of Participants	92.3 Percentage of Participants

SECONDARY outcome

Timeframe: Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)

Population: PK evaluable population. This population is defined as all randomized participants regardless of whether the assigned study treatment was received. For PK analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=377 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Cycle 8, Day 1, pre-dose	157 microgram/mL Geometric Coefficient of Variation 305.9	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Cycle 12, Day 1, pre-dose	155 microgram/mL Geometric Coefficient of Variation 497.4	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Cycle 16, Day 1, pre-dose	137 microgram/mL Geometric Coefficient of Variation 144.9	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Safety visit	2.69 microgram/mL Geometric Coefficient of Variation 1759.3	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Study Completion/Early Discontinuation	82.3 microgram/mL Geometric Coefficient of Variation 1008.1	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Study Completion/Early Discontinuation pre-dose	65.3 microgram/mL Geometric Coefficient of Variation 106.9	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Unscheduled	50.5 microgram/mL Geometric Coefficient of Variation NA There was only 1 patient for Cmin Unscheduled visit, therefore CV% mean cannot be calculated.	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Unscheduled Predose	32.9 microgram/mL Geometric Coefficient of Variation 326.5	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Cycle 2, Day 1, pre-dose	76.4 microgram/mL Geometric Coefficient of Variation 69.4	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Cycle 3, Day 1, pre-dose	124 microgram/mL Geometric Coefficient of Variation 79.5	—
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Cycle 4, Day 1, pre-dose	147 microgram/mL Geometric Coefficient of Variation 65.1	—

SECONDARY outcome

Timeframe: Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min])

Population: PK evaluable population. This population is defined as all randomized participants regardless of whether the assigned study treatment was received. For PK analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.

Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=281 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Maximum Observed Serum Concentration (Cmax) of Atezolizumab	365 Microgram/mL Geometric Coefficient of Variation 26.5	—

SECONDARY outcome

Timeframe: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8

Population: PK evaluable population

Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=141 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=137 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Plasma Concentration of Enzalutamide Cycle 1 Day 1 1 Hr Post	1.51 Microgram/mL Geometric Coefficient of Variation 406.4	2.42 Microgram/mL Geometric Coefficient of Variation 270.6
Plasma Concentration of Enzalutamide Cycle 3 Day 1 Predose	13.1 Microgram/mL Geometric Coefficient of Variation 29.0	13.8 Microgram/mL Geometric Coefficient of Variation 20.7
Plasma Concentration of Enzalutamide Cycle 3 Day 1 1 Hr Post	14.2 Microgram/mL Geometric Coefficient of Variation 27.3	16.0 Microgram/mL Geometric Coefficient of Variation 19.8
Plasma Concentration of Enzalutamide Cycle 8 Day 1 Predose	11.3 Microgram/mL Geometric Coefficient of Variation 103.7	12.6 Microgram/mL Geometric Coefficient of Variation 30.5
Plasma Concentration of Enzalutamide Unscheduled Predose	—	10.5 Microgram/mL Geometric Coefficient of Variation NA There was only one patient at unscheduled predose visit, therefore no Geometric Coefficient of Variation values can be calculated

SECONDARY outcome

Timeframe: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8

Population: PK evaluable population

Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=141 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=137 Participants Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Plasma Concentration of N-Desmethyl Enzalutamide Cycle 1 Day 1 1 Hr Post	0.02 Microgram/mL Geometric Coefficient of Variation NA N/A represents data that are not evaluable. Lower Than Reportable data.	0.03 Microgram/mL Geometric Coefficient of Variation NA N/A represents data that are not evaluable. Lower Than Reportable data.
Plasma Concentration of N-Desmethyl Enzalutamide Cycle 3 Day 1 Predose	11.9 Microgram/mL Geometric Coefficient of Variation 33.1	11.9 Microgram/mL Geometric Coefficient of Variation 28.8
Plasma Concentration of N-Desmethyl Enzalutamide Cycle 3 Day 1 1 Hr Post	10.6 Microgram/mL Geometric Coefficient of Variation 34.2	10.9 Microgram/mL Geometric Coefficient of Variation 29.8
Plasma Concentration of N-Desmethyl Enzalutamide Cycle 8 Day 1 Predose	12.8 Microgram/mL Geometric Coefficient of Variation 36.8	13.1 Microgram/mL Geometric Coefficient of Variation 32.6
Plasma Concentration of N-Desmethyl Enzalutamide Unscheduled Predose	—	13.3 Microgram/mL Geometric Coefficient of Variation NA There was only one patient at unscheduled predose visit, therefore no Geometric Coefficient of Variation values can be calculated

SECONDARY outcome

Timeframe: Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months

Population: The safety population is defined as participants who received any amount of any component of the study treatments (atezolizumab, or enzalutamide). Participants will be allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to enzalutamide alone who received at least one full or partial dose of atezolizumab will be included in the atezolizumab arm for safety).

The numbers and proportions of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.

Enzalutamide Arm has no Atezolizumab dosing therefore no participants to include here for Atezolizumab ADA.

Outcome measures

Measure	Atezolizumab + Enzalutamide n=386 Participants Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Participants positive for Treatment Emergent ADA: treatment induced	52 Participants	—
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab With Positive Sample at Baseline	2 Participants	—
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Without Positive Sample at Baseline	368 Participants	—
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Participants positive for Treatment Emergent ADA: treatment enhanced	0 Participants	—
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab Participants negative for Treatment Emergent ADA	320 Participants	—

Adverse Events

Atezolizumab + Enzalutamide

Serious events: 139 serious events

Other events: 339 other events

Deaths: 219 deaths

Enzalutamide

Serious events: 87 serious events

Other events: 309 other events

Deaths: 191 deaths

Serious adverse events

Measure	Atezolizumab + Enzalutamide n=374 participants at risk Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=376 participants at risk Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	2.4% 9/374 • Number of events 11 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	2.9% 11/376 • Number of events 15 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Blood and lymphatic system disorders Leukopenia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Blood and lymphatic system disorders Neutropenia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Acute coronary syndrome	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Acute myocardial infarction	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Arrhythmia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Atrial fibrillation	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Atrial flutter	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Autoimmune myocarditis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Cardiac arrest	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Cardiac disorder	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Cardiac failure	1.1% 4/374 • Number of events 4 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 4 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Cardiac failure congestive	0.27% 1/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Cardiopulmonary failure	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Coronary artery disease	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Left ventricular failure	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Myocardial infarction	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Myocardial ischaemia	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Myocarditis	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Sinus bradycardia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Cardiac disorders Ventricular fibrillation	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Endocrine disorders Adrenal insufficiency	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Endocrine disorders Hypothyroidism	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Eye disorders Uveitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Abdominal pain	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Colitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Constipation	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Diarrhoea	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Diverticular perforation	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Enteritis	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Intestinal obstruction	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Nausea	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Small intestinal obstruction	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Vomiting	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Asthenia	1.3% 5/374 • Number of events 5 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Chest pain	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Complication of device insertion	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Death	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Fatigue	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.80% 3/376 • Number of events 4 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders General physical health deterioration	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Influenza like illness	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Malaise	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Multiple organ dysfunction syndrome	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Necrosis	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Non-cardiac chest pain	0.53% 2/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Oedema	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Pain	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Pyrexia	1.6% 6/374 • Number of events 7 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 7 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Hepatobiliary disorders Hepatitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Immune system disorders Anaphylactic reaction	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Immune system disorders Hypersensitivity	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Bacteraemia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Cellulitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Clostridium difficile colitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Encephalitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Infected cyst	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Infection	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Influenza	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Neutropenic sepsis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Nosocomial infection	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Pneumonia	2.7% 10/374 • Number of events 10 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	2.7% 10/376 • Number of events 13 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Pneumonia legionella	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Pyelonephritis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Sepsis	1.1% 4/374 • Number of events 4 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	1.1% 4/376 • Number of events 4 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Septic shock	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Spinal cord infection	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Superinfection	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Urinary tract infection	1.1% 4/374 • Number of events 5 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Urosepsis	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Fall	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Femur fracture	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Infusion related reaction	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Jaw fracture	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Multiple injuries	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Subdural haematoma	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Alanine aminotransferase increased	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Aspartate aminotransferase increased	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Blood bilirubin increased	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Blood creatine phosphokinase increased	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Lymphocyte count decreased	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Platelet count decreased	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Troponin increased	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Decreased appetite	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Hypercalcaemia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Hypocalcaemia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Hypokalaemia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 4/374 • Number of events 4 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Back pain	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	1.3% 5/376 • Number of events 5 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Bone pain	1.9% 7/374 • Number of events 8 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Muscle spasms	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Muscular weakness	0.53% 2/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Myalgia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Myositis	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Neck pain	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Pathological fracture	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Torticollis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour rupture	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Cerebral infarction	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Cerebrovascular accident	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Cranial nerve palsies multiple	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Encephalopathy	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Headache	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Hypoaesthesia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders IIIrd nerve paralysis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Ischaemic stroke	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Lacunar infarction	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Lethargy	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Myasthenic syndrome	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Neuropathy peripheral	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Paraesthesia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Paralysis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Paraparesis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Peripheral motor neuropathy	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Seizure	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Spinal cord compression	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Subarachnoid haemorrhage	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Syncope	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Transient ischaemic attack	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Psychiatric disorders Anxiety	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Psychiatric disorders Confusional state	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Psychiatric disorders Delirium	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Acute kidney injury	1.3% 5/374 • Number of events 5 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Haematuria	1.9% 7/374 • Number of events 13 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	1.3% 5/376 • Number of events 7 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Hydronephrosis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Renal failure	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Urinary retention	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.53% 2/376 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Erythema	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Erythema multiforme	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Rash	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.80% 3/374 • Number of events 3 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Surgical and medical procedures Bladder neoplasm surgery	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Haematoma	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Hypertension	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Hypertensive crisis	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Hypotension	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Pelvic venous thrombosis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Peripheral artery thrombosis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Blood and lymphatic system disorders Myelosuppression	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Eye disorders Papilloedema	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Dyspepsia	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Unevaluable event	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Hepatobiliary disorders Hypertransaminasaemia	0.53% 2/374 • Number of events 2 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Pneumonia aspiration	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Postoperative abscess	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Humerus fracture	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Injury	0.00% 0/374 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.27% 1/376 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Renal and urinary disorders Nephritis	0.27% 1/374 • Number of events 1 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	0.00% 0/376 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.

Other adverse events

Measure	Atezolizumab + Enzalutamide n=374 participants at risk Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.	Enzalutamide n=376 participants at risk Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	22.2% 83/374 • Number of events 98 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	13.0% 49/376 • Number of events 58 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Endocrine disorders Hypothyroidism	5.6% 21/374 • Number of events 22 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	1.3% 5/376 • Number of events 5 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Constipation	20.9% 78/374 • Number of events 88 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	16.5% 62/376 • Number of events 65 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Diarrhoea	23.0% 86/374 • Number of events 109 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	10.9% 41/376 • Number of events 51 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Nausea	23.0% 86/374 • Number of events 95 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	17.6% 66/376 • Number of events 73 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Gastrointestinal disorders Vomiting	8.3% 31/374 • Number of events 35 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	8.5% 32/376 • Number of events 35 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Asthenia	21.9% 82/374 • Number of events 99 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	16.8% 63/376 • Number of events 68 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Fatigue	34.2% 128/374 • Number of events 148 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	27.4% 103/376 • Number of events 116 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Oedema peripheral	8.8% 33/374 • Number of events 38 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	7.4% 28/376 • Number of events 31 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Pain	6.4% 24/374 • Number of events 26 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	3.5% 13/376 • Number of events 13 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
General disorders Pyrexia	8.3% 31/374 • Number of events 37 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	2.4% 9/376 • Number of events 9 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Nasopharyngitis	3.5% 13/374 • Number of events 15 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	5.6% 21/376 • Number of events 24 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Urinary tract infection	5.3% 20/374 • Number of events 24 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	4.8% 18/376 • Number of events 21 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Investigations Weight decreased	13.6% 51/374 • Number of events 54 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	8.5% 32/376 • Number of events 33 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Metabolism and nutrition disorders Decreased appetite	30.7% 115/374 • Number of events 129 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	27.7% 104/376 • Number of events 120 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 80/374 • Number of events 108 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	17.0% 64/376 • Number of events 94 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Back pain	21.4% 80/374 • Number of events 98 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	14.6% 55/376 • Number of events 63 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Bone pain	7.2% 27/374 • Number of events 31 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	9.0% 34/376 • Number of events 38 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.6% 21/374 • Number of events 25 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	4.0% 15/376 • Number of events 16 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 26/374 • Number of events 32 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	10.4% 39/376 • Number of events 46 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Dizziness	7.0% 26/374 • Number of events 31 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	5.6% 21/376 • Number of events 27 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Nervous system disorders Headache	8.3% 31/374 • Number of events 34 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	5.1% 19/376 • Number of events 21 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Psychiatric disorders Insomnia	7.8% 29/374 • Number of events 29 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	7.7% 29/376 • Number of events 30 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 21/374 • Number of events 22 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	4.5% 17/376 • Number of events 18 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.4% 24/374 • Number of events 26 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	4.5% 17/376 • Number of events 19 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Pruritus	9.6% 36/374 • Number of events 43 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	2.1% 8/376 • Number of events 8 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Skin and subcutaneous tissue disorders Rash	13.6% 51/374 • Number of events 59 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	2.7% 10/376 • Number of events 10 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Hot flush	2.9% 11/374 • Number of events 11 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	5.6% 21/376 • Number of events 23 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Vascular disorders Hypertension	7.2% 27/374 • Number of events 33 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	5.9% 22/376 • Number of events 22 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Infections and infestations Upper respiratory tract infection	5.1% 19/374 • Number of events 21 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	3.7% 14/376 • Number of events 15 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Injury, poisoning and procedural complications Fall	5.6% 21/374 • Number of events 26 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.	5.1% 19/376 • Number of events 27 • From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period. 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

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